Document ID: FDA-2014-V-1913-0004
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-11-18T05:00Z

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<TITLE>Submission Report</TITLE>
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<font face="arial,helvetica,georgia,verdana" size="4"><b>Submission Report</b></font>
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<font face="arial,helvetica,georgia,verdana" size="3"><b>eRadHealth Menu</b></font>
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<font face="arial,helvetica,georgia,verdana" size="2">Introduction</font>
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<head></head><body><h1 align="center" style="margin-right: 0.0; margin-left:0.0; text-indent: 0.0">Electronic Product Radiation Safety Reporting Form</h1><p>This software application is intended to automate the hard copy product reporting forms in the effort of the Center for Devices and Radiological Health (CDRH) to become capable of accepting electronic submissions from industry and to improve our review process. This FDA Electronic Submission (eSub) software is the next version of the application developed to allow us to accept all Radiological Health reports and other submissions electronically and improve the ability of CDRH to accomplish its mandated product and industry evaluations in a timely and efficient manner.</p><p>All electronic reports and correspondence can either be transferred to CD and mailed to the address below, or can be sent via the FDA Electronic Submissions Gateway to CDRH.  If you follow instructions to set up an account with the FDA Gateway, it currently may take several weeks,, but when you submit through it you will receive your acknowledgement email message with Accession Number within minutes!   Or, in the interest of faster turn-around for a one-time urgent report of if you submit few reports, you may simply fill out this template creating the submission and then at 'Packaging' follow the instructions to transfer the files to a CD to mail in. This method of submitting your report will be acknowledged by an email with the Accession Number within several days. </p><p>
Information about the FDA Electronic Submissions Gateway can be found at <b><a href="http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm">www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm</a></b>.  Please contact the Gateway Helpdesk with your questions about that system.
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Electronic submissions on CD should be mailed directly to the Document Control Center at:</p><br><b>U.S. Food and Drug Administration<br>Center for Devices and Radiological Health<br>Attn: eSubmitter Team<br>Document Mail Center - WO66-0609<br>10903 New Hampshire Avenue<br>Silver Spring, MD 20993-0002</b></p>
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Submissions received in the mail on CD will be processed within a few days of receipt.</p>
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<b><u>Note about eSubmitter software: </u></b>
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Instructions provided in this software briefly summarize the requirements of the regulations under the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control, that applies to manufacturers of electronic products that emit radiation. The software provides questions relevant to requirements in the performance standards and may include explanations or clarification about the performance, labeling, and informational requirements of the standard. It does not replace the regulations, however, and if there is any conflict between the software and the regulations, the regulations must prevail. Throughout this application, pertinent sections of Title 21, Code of Federal Regulations, Chapter I, Subchapter J, are cited in parentheses. Please consult them before making design or procedural decisions.  </p>
<p> Regulatory requirements for radiological products can be found at <b><a href="http://www.fda.gov/cdrh/radhealth/">http://www.fda.gov/Radiation-EmittingProducts/default.htm</a></b> and for medical devices are located at <b><a href="http://www.fda.gov/cdrh/devadvice/">www.fda.gov/M/devaDvices/default.htm</a></b>.  If you have specific questions about the regulations, please contact us at: <b><a href="mailto:DSMICA@fda.hhs.gov">DSMICA@fda.hhs.gov</a></b>.

<p>If you have specific questions regarding this software, please contact the eSub team by email at: <b><a href="mailto:eSubmitter@fda.hhs.gov">eSubmitter@fda.hhs.gov</a></b>.</p><p>Thank you for using our electronic product reporting software. Please communicate your comments and suggestions to the eSub team as often as you like.</p><p>Thank you for your continued support of the FDA Electronic Submission Program (eSub).</p>
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<center>An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection is 0910-0025 (expires January 31, 2017).<br></center></body></html>
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<font face="arial,helvetica,georgia,verdana" size="2">Role</font>
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<font face="arial,helvetica,georgia,verdana" size="1">What is your role?</font>
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<font face="arial,helvetica,georgia,verdana" size="2">!*</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Manufacturer</font>
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<font face="arial,helvetica,georgia,verdana" size="1"><i>Information:</i></font>
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<font face="arial,helvetica,georgia,verdana" size="1"><i>The following screen provides several options for you to accurately define what type of eSubmission you intend to create for FDA.  Below are explanations of your options.  Please feel free to review this screen, advance to the next screen and view the picklists, but if you're confused, come back to read this screen again to be certain you are selecting the correct report or correspondence type you want to create.</i></font>
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<font face="arial,helvetica,georgia,verdana" size="2">Submission Information</font>
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<font face="arial,helvetica,georgia,verdana" size="1"><b>Step 1</b></font>
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<font face="arial,helvetica,georgia,verdana" size="1"><b>Use the radio buttons to identify the type of submission you are preparing. (Supplements should be prepared using the same document type as the original submission.)</b></font>
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<font face="arial,helvetica,georgia,verdana" size="1">What Type of Submission is this?  (Supplements should be submitted selecting the same document type as the original report.)</font>
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<font face="arial,helvetica,georgia,verdana" size="2">!*</font>
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<font face="arial,helvetica,georgia,verdana" size="1">(<font face="courier new" size="1"> </font><font face="arial,helvetica,georgia,verdana" size="1">)  Radiation Safety Report (Product) Report (21 CFR 1002.10)</font><br>(<font face="courier new" size="1"> </font><font face="arial,helvetica,georgia,verdana" size="1">)  Annual Report (21 CFR 1002.13)</font><br>(<font face="courier new" size="1"> </font><font face="arial,helvetica,georgia,verdana" size="1">)  Laser Light Show Documents (all relevant documents) (21 CFR 1040.11(c))</font><br>(<font face="courier new" size="1"> </font><font face="arial,helvetica,georgia,verdana" size="1">)  Correspondence</font><br>(<font face="courier new" size="1">•</font><font face="arial,helvetica,georgia,verdana" size="1">)  Variance Request (General, not Laser Light Show) (21 CFR 1010.4)</font><br>(<font face="courier new" size="1"> </font><font face="arial,helvetica,georgia,verdana" size="1">)  Laser Original Equipment/Component Manufacturer Registration (21 CFR 1040.10(a)(3)(ii))</font><br>(<font face="courier new" size="1"> </font><font face="arial,helvetica,georgia,verdana" size="1">)  Abbreviated Report (21 CFR 1002.12)</font></font>
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<font face="arial,helvetica,georgia,verdana" size="1"><b>Step 2</b></font>
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<font face="arial,helvetica,georgia,verdana" size="1"><b>After answering the Submission Type question above, one of the questions below may become active and required (see the blue dot to the right of the question).  If there is an active question, select the appropriate product area or document type from the question's pick list.</b></font>
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<font face="arial,helvetica,georgia,verdana" size="1">What Type of Product is this Radiation Safety Report about?</font>
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<font face="arial,helvetica,georgia,verdana" size="1"> </font>
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<font face="arial,helvetica,georgia,verdana" size="1">What Type of Product is this Annual Report about?</font>
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<font face="arial,helvetica,georgia,verdana" size="1">What Laser Light Show Document are you filing?</font>
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<font face="arial,helvetica,georgia,verdana" size="1">What Type of Correspondence is this?</font>
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<font face="arial,helvetica,georgia,verdana" size="1">What Type of Product is this Variance Request about?</font>
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<font face="arial,helvetica,georgia,verdana" size="2">!*</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Laser Products (Includes Projection Systems)</font>
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<font face="arial,helvetica,georgia,verdana" size="3"><b>Manufacturer Data</b></font>
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<font face="arial,helvetica,georgia,verdana" size="2">Manufacturer Responsible for Product Compliance</font>
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<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
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<font face="arial,helvetica,georgia,verdana" size="1"><i>This is the firm that takes responsibility for certification that the product meets the performance standard.  This firm develops and maintains the quality control and testing program that is the basis for the certification of this product.  Additionally, this firm usually is the owner of the product design and manufacturing process design.<br><br>Be sure to enter address information for each tab below:</i></font>
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<font face="arial,helvetica,georgia,verdana" size="1">Select the Manufacturer's address from the Establishment Address book:</font>
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<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<font face="arial,helvetica,georgia,verdana" size="1"><i>Establishment Information:</i></font>
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<font face="arial,helvetica,georgia,verdana" size="1">Establishment Name</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Mettler-Toledo AutoChem</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Division Name</font>
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<font face="arial,helvetica,georgia,verdana" size="1"> </font>
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<font face="arial,helvetica,georgia,verdana" size="1">Home Page</font>
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<font face="arial,helvetica,georgia,verdana" size="1"> </font>
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<font face="arial,helvetica,georgia,verdana" size="1"><i>Physical Location:</i></font>
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<font face="arial,helvetica,georgia,verdana" size="1">Address</font>
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<font face="arial,helvetica,georgia,verdana" size="1">7075 Samuel Morse Drive<br>Suite 100<br>Columbia, MD, 21046, US</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Telephone Number</font>
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<font face="arial,helvetica,georgia,verdana" size="1">(410) 910-8100</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Fax Number</font>
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<font face="arial,helvetica,georgia,verdana" size="1"> </font>
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<font face="arial,helvetica,georgia,verdana" size="1"><i>Mailing Location:</i></font>
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<font face="arial,helvetica,georgia,verdana" size="1">Address</font>
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<font face="arial,helvetica,georgia,verdana" size="1">7075 Samuel Morse Drive<br>Suite 100<br>Columbia, MD, 21046, US</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Telephone Number</font>
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<font face="arial,helvetica,georgia,verdana" size="1">(410) 910-8100</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Fax Number</font>
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<font face="arial,helvetica,georgia,verdana" size="1"> </font>
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<font face="arial,helvetica,georgia,verdana" size="2">Responsible Individual</font>
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<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
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<font face="arial,helvetica,georgia,verdana" size="1"><i>The responsible individual is the highest level and most responsible individual affiliated with this establishment.</i></font>
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<font face="arial,helvetica,georgia,verdana" size="1">Select the Responsible Individual from the Contact Address book:</font>
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<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<font face="arial,helvetica,georgia,verdana" size="1"><i>Contact Information:</i></font>
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<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Contact Name</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Brenda Desormeaux</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Occupation Title</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Quality Manager</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Email Address</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">brenda.desormeaux@mt.com</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Establishment Information:</i></font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Establishment Name</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Mettler-Toledo AutoChem</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Division Name</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Physical Location:</i></font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Address</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">7075 Samuel Morse Drive<br>Suite 100<br>Columbia, MD, 21046, US</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Telephone Number</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">(410) 910-8100</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Fax Number</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Mailing Location:</i></font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Address</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">7075 Samuel Morse Drive<br>Suite 100<br>Columbia, MD, 21046, US</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Telephone Number</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">(410) 910-8100</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Fax Number</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">Manufacturer's Reporting Official</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>This is the person at the manufacturing facility that is knowledgeable and responsible for addressing all aspects of the testing and quality control procedures for certification as reported to FDA in the product report.  Documentation of changes intesting and quality control procedures submitted to FDA must be signed by this individual.</i></font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Select the Reporting Official from Contact Address book:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Contact Information:</i></font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Contact Name</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Brenda Desormeaux</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Occupation Title</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Email Address</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">brenda.desormeaux@mt.com</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Establishment Information:</i></font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Establishment Name</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Mettler-Toledo AutoChem</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Division Name</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Physical Location:</i></font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Address</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">7075 Samuel Morse Drive<br>Suite 100<br>Columbia, MD, 21046, US</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Telephone Number</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">(410) 910-8100</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Fax Number</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Mailing Location:</i></font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Address</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">7075 Samuel Morse Drive<br>Suite 100<br>Columbia, MD, 21046, US</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Telephone Number</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">(410) 910-8100</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Fax Number</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">Report Submitter</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>The submitter may be a consulting individual or firm providing assistance in report preparation and maintenance.  Documents or submissions such as this one that are prepared by the submitter must have an accompanying authorization letter from the manufacturer's reporting official for authenticity.</i></font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Select the Submitter from the Contact Address book:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Contact Information:</i></font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Contact Name</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Brenda Desormeaux</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Occupation Title</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Quality Manager</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Email Address</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">brenda.desormeaux@mt.com</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Establishment Information:</i></font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Establishment Name</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Mettler-Toledo AutoChem</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Division Name</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Physical Location:</i></font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Address</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">7075 Samuel Morse Drive<br>Suite 100<br>Columbia, MD, 21046, US</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Telephone Number</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">(410) 910-8100</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Fax Number</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Mailing Location:</i></font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Address</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">7075 Samuel Morse Drive<br>Suite 100<br>Columbia, MD, 21046, US</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Telephone Number</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">(410) 910-8100</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Fax Number</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Comments:</i></font>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="50%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Internal Reference Number:</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">Manufacturer Designated United States Agent</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Manufacturers exporting to the U.S. must designate a U.S. agent, see 21 CFR 1005.25.</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="78%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Is there a United States agent that has been designated by the manufacturer?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Not Applicable</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">Importer</font>
</td>
</tr>
</table>
<p style="page-break-before: always"></p>
<table border="1" bordercolor="black" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="3"><b>Product Data</b></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2"></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">Product and Model Identification</font>
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<html><head></head><body style="background-color: '#ddFFdd'"><h1 align="center" style="margin-right: 0.0; text-indent: 0.0; margin-left: 0.0">Attention - Information about this section</h1><br>In this section you'll be asked to identify several required or optional things which will help FDA/CDRH staff to prioritize their reviews.  You'll be asked to consider the following aspects: </br>

<p>(1) Identify your product's radiation type and the CDRH Product Code.</p>
<p>
(2) Enter an Accession number if this will be a report supplment.  If you are preparing a supplement, you'll see that after entering a valid 7-digit  Accession number many questions will no longer be required (they will either be disabled or will be optional, meaning they will no longer have the blue dot).</p>
<p>
(3) You will also have several questions that are of high significance for FDA/CDRH - why you might be submitting this report or correspondence.  Please read these questions carefully, referring to the 21 CFR regulations on the website <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPartFrom=1000&CFRPartTo=1050">www.FDA.gov</a> if you are unsure if the question is relevant to your firm's situation. </p>
<p>
(4) If you find that you have more information that you want the FDA/CDRH to read but it doesn't seem to fit under other questions, we have a final "<b><i>Additional Information</i></b>" question in this section which invites you to add comments and/or attach a file that provides further information from your firm about this submission.  This is the place to add that extra information.</p><br></br></body>
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<font face="arial,helvetica,georgia,verdana" size="2">Product Type Reported</font>
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<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">What is the product code?<br><br>To select the three letter product code,<br><br>- Click the plus sign. You will see a product code filter dialog box.<br>- Select the appropriate category name from the pick list. You will be provided a list of product codes from which to choose.  <br>- Select the best match to your product.<br>- The remaining fields will be filled in for you when you select your product code.</font>
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<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Category</font>
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<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">RESEARCH, SCIENTIFIC, LABORATORY LASER PRODUCTS (44)</font>
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<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Product Code</font>
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<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">PARTICLE-SIZE MEASURING INSTRUMENT (REN)</font>
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<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Performance Standard</font>
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<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">LASER PRODUCTS. (1040.10)</font>
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<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">If Other, provide a category name for this specific product.</font>
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<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
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<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">Report Information</font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="84%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Is this the first time you've submitted a report on the particular type of product selected in the Product Type Reported section?</font>
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<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
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<td width="84%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Since this is not the first time you've reported on this type of product, then is this a report supplement to a previously reported model family?</font>
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<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
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<td width="86%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Provide the Accession Number of the original report for which this is a supplement:<br>(Note: Do not enter any Device Premarket Application or Notification document number here, such as PMAs, 510(k)s, IDEs, etc.  See Accession number description below.)</font>
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<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="80%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Are you requesting a new variance, a renewal, extension or amendment to a previous variance?</font>
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<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">New Variance</font>
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<td width="80%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">If you have a Docket Number that was issued by FDA's Division of Dockets Management, please provide it here.</font>
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<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
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</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">Special Considerations</font>
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<br>
<hr size="1"></hr>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">Noncompliances or Defects</font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><b>Does this document or any of its attachments contain:</b></font>
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<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">A notification of noncompliance or defect?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
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</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">You may provide an explanation and/or attach a document here:</font>
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<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Details</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
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<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">Responses to Noncompliances or Defects</font>
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<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><b>Does this document or any of its attachments contain any of these responses concerning noncompliances or defects?</b></font>
</td>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">A refutation of noncompliances or defects identified to your firm?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
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</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">A request for an exemption from notification to purchasers (see 21 CFR 1003.21 and 1003.30)?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
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</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Corrective action plans you intend to implement to correct noncompliances or defects discovered in past or current production?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
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</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>If you are submitting a Corrective Action Plan (CAP) following 21 CFR 1004 and information on design changes for future production, the design change information must be submitted in a Radiation Safety (Product) Report or supplemental report.  Both the proposed CAP and the design changes may be submitted in one document if you prepare a product report and choose to include the CAP in it as a file attachment.  Alternatively, you may create a separate eSubmission for the CAP using the "Correspondence" type template and selecting "Follow-up correspondence to FDA."</i></font>
</td>
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</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">A description of any design changes that correct noncompliances for future production?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
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</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>If you are submitting information on product design changes for future production due to a discovery of noncompliances or defects in current production,  you must  use the Radiation Safety (Product) Report template to create the report . Correspondence templates may be used to submit other information such as a proposed corrective action plan pertaining to a noncompliance or defect.</i></font>
</td>
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</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">You may add an explanation and/or attach a document here:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Details</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">Exemption Requests</font>
</td>
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<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><b>Does this document or any of its attachments contain:</b></font>
</td>
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</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Exemption of a product for government use from a standard (21 CFR 1010.5)?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
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</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Exemption for products for government use from reporting and recordkeeping (21 CFR 1002.51)?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Special exemption of products from reporting and/or recordkeeping (21 CFR 1002.50)?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Request for approval of alternate labeling?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Yes</font>
</td>
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</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Application for alternate test procedures (21 CFR 1010.13)?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">You may provide an explanation and/or attach any relevant documents here:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
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</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Area for labeling on the product is too small for certification labeling. Certification label is located in the Safety Manual.</font>
</td>
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<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\MK-PB-0113-AC ParticleView V19 Safety Manual.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">ParticleView V19 Safety Manual</a></font>
</td>
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</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">Variance Requests</font>
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</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Information:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Please note: in addition to responding to these questions below, a separate General Variance Request or Laser Light Show Variance Request form must be completed and submitted to CDRH, with a hard copy sent to FDA's Division of Dockets Management as instructed below for any variance request.  The  information requested on this screen does not constitute the full structured content of the variance request.  The 2 types of Variance forms can be created in eSubmitter by  selecting the appropriate Variance submission type under the eRad Health Menu section of this application.</i></font>
</td>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Message:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Click the plus sign to list the requirements from which you are requesting a variance.</i></font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">This submission includes an application for a variance from certain requirements.</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
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</table>
</td>
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<tr align="left" valign="top">
<td width="8%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Item 1</font>
</td>
<td width="92%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">[1010.2] Certification Label</font>
</td>
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</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Provide an explanation and attach supporting files, if necessary.  Click on the plus sign below to attach files.</font>
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</table>
</td>
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<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Details</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><html>
  <head>

  </head>
  <body>
    <p style="margin-top: 0">
      Area on the product for applying the certification label is too small. 
      Device is Class 1. Requesting variance to put the certification label in 
      the Safety Manual. See attached manual.
    </p>
  </body>
</html></font>
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<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\MK-PB-0113-AC ParticleView V19 Safety Manual.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">ParticleView V19 Safety Manual</a></font>
</td>
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</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Stop:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>For all Variance requests, two submissions must be made to the FDA.  <br><br>The electronic version should be submitted following the Packaging Files for Submission instructions located under Output in the Menu bar, and explained in subsection 4.3 of the User Manual.  If sending a CD & submittal letter, please mail to: <br><br>U.S. Food and Drug Administration<br>Center for Devices and Radiological Health<br>Attn: eSubmitter Team<br>Document Mail Center - WO66-0609<br>10903 New Hampshire Avenue<br>Silver Spring, MD 20993-0002<br><br>Additionally, a paper version (hard-copy) of the signed Variance request document should be submitted to:<br><br>Food and Drug Administration<br>Division of Dockets Management (HFA-305)<br>5630 Fishers Lane, Room 1061<br>Rockville, MD 20857</i></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">Responses to Communications from FDA</font>
</td>
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</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><b>Does this document or any of its attachments contain:</b></font>
</td>
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</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="84%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">A response to an FDA inspection?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
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</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="84%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">What was the date of the inspection?</font>
</td>
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</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="84%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">A response to a Warning letter or a Notification of Noncompliance or Defect from the FDA?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="84%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">What was the date of the Warning Letter or other notification letter?</font>
</td>
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</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="84%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">A response to a report review inquiry from the CDRH (the inquiry may have been in the form of a letter, email, or phone call)?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="84%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">What was the date of the inquiry?</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="84%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">A response to any other communication from FDA?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="84%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">What was the date of the communication?</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Provide an explanation:</font>
</td>
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</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">Additional Information</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Here's your opportunity to add anything else to this submission that you want to tell the FDA!  <br><br>Is there any other relevant information or additional comments that would help expedite the review of this submission?  Click the plus sign below to attach any supporting files.</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Details</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">Private Labeling</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Is the product sold by other companies under different brand names?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">Medical Devices</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Provide the premarket 510(k), IDE, HDE, PDP, or PMA filing numbers related to this medical product, if one of these numbers has been assigned by FDA yet.</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">not applicable</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">If it has not been submitted yet, or if your device is exempt from premarket clearance or approval, please provide an explanation.  The device regulations can be found in 21 CFR 807 - device manufacturer registration and device listing.</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">not a medical product</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<p style="page-break-before: always"></p>
<table border="1" bordercolor="black" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="3"><b>Laser Product</b></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2"></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">PART 1: DEFINITIONS</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<html><head></head><body><h1 style="margin-right: 0.0; margin-left: 0.0; text-indent: 0.0" align="center">GENERAL DEFINITIONS</h1><p>This software application should be followed for all lasers and products containing, incorporating, or intended to incorporate, a laser or laser system [see the definition of "laser product" in section 21 CFR1040.10(b)(21)]. A separate form for reporting additional information concerning laser light shows is being published concurrently with this form and must be used in conjunction with this form when appropriate (Reporting Guide for Laser Light Shows and Displays).</p><h3></h3><h3>Laser Reporting and Recordkeeping (21 CFR 1002)</h3><p>Applicability of reporting and recordkeeping requirements for laser products:</p><p style="margin-right: 0.0; margin-left: 20.0; text-indent: 0.0" align="left">Class I, IIa, II, and IIIa laser products and laser products containing such lasers will require: Product Report, Annual Report, test records,manufacturer's distribution records, and dealer/distributor distribution records.</p><p style="margin-right: 0.0; margin-left: 20.0; text-indent: 0.0" align="left">Note that for Class I laser products containing lasers of Class I, IIa, II, or IIIa no Supplemental Reports are required. Furthermore, some Class I laser products have already been exempted from the requirement for distribution records (see Notice to Industry dated August 9, 1988, Laser Notice # 41).</p><p style="margin-right: 0.0; margin-left: 20.0; text-indent: 0.0" align="left">Class IIIb and IV laser products require all of the above plus Supplemental Reports when the criteria requiring submission of Supplemental Reports are met.</p><p></p><p>The laser standard applies to all laser products manufactured after August 1, 1976 (1040.10(a)), unless the products are either: sold to a manufacturer for use as components (or replacements) in products that will be certified (1040.10(a)(l)); sold by or for a manufacturer as repair or replacement components if they are properly labeled as such and have installation instructions (1040.10)(a)(2)); or intended for export only, are labeled as such, and comply with the requirements of the importing country (1010.20). Manufacturers of laser products that are sold to other manufacturers for use as components in their products are required to register and list such products.</p><p></p><h3>Laser Definitions from 21 CFR 1040.10(b)</h3><p><b>Laser</b> means any product that can be made to produce or amplify electromagnetic radiation at wavelengths greater than 250 nm but less than or equal to 13,000 nm or, after August 20, 1986, at wavelengths equal to or greater than 180 nm but less than or equal to 1.0 x 10 to the power of 6 nm primarily by the process of controlled stimulated emission.</p><p><b>Laser energy source</b> means any product intended for use in conjunction with a laser to supply energy for the operation of the laser. General energy sources such as electrical supply mains or batteries shall not be considered to constitute laser energy sources.</p><p><b>Laser product </b>means any manufactured product or assemblage of components which constitutes, incorporates, or is intended to incorporate a laser or laser system. A laser or laser system that is intended for use as a component of an electronic product shall itself be considered a laser product  (1040.10(b)(21)).</p><p><b>Laser radiation</b> means all electromagnetic radiation emitted by a laser product within the spectral range specified in paragraph1040.10(b)(19) that is produced as a result of controlled stimulated emission or that is detectable with radiation so produced through the appropriate aperture stop and within the appropriate solid angle of acceptance, as specified in 1040.10(e).</p><p><b>Laser system</b> means a laser in combination with an appropriate laser energy source with or without additional incorporated components. See paragraph 1040.10(c)(2) of the laser product performance standard for an explanation of the term "removable laser system."</p><h3></h3><h3>Specific-Purpose Products</h3><p><b>Medical laser product</b> means any laser product which is a medical device as defined in 21 U.S.C. 321(h) and is manufactured, designed, intended or promoted for in vivo laser irradiation of any part of the human body for the purpose of: (i) Diagnosis, surgery, or therapy; or (ii) relative positioning of the human body. Class IIIa, IIIb, and IV medical laser products must contain a means for measuring the delivered exposure or treatment level of radiation, accurate within plus or minus 20 percent. This requirement is not applicable to Class IIIa aiming devices except ophthalmic application.The instruction manual must include a procedure and schedule for recalibration of the measurement system. A modified aperture label is also specified (1040.11(a)).</p><p><b>Surveying, leveling, or alignment laser product</b> means a laser product manufactured, designed, intended or promoted for one or more of the following uses:</p><p style="margin-right: 0.0; margin-left: 20.0; text-indent: 0.0" align="left">(i) Determining and delineating the form, extent, or position of a point, body, or area by taking angular measurement.</p><p style="margin-right:0.0; margin-left: 20.0; text-indent: 0.0" align="left">(ii) Positioning or adjusting parts in proper relation to one another.</p><p style="margin-right: 0.0; margin-left: 20.0; text-indent: 0.0" align="left">(iii) Defining a plane, level, elevation, or straight line.</p><p style="margin-right: 0.0; margin-left: 0.0; text-indent: 0.0" align="left">Surveying, leveling, and alignment laser products are generally used in agriculture and in the construction industry. They are restricted to 5mW visible radiant power and to Class I for other wavelengths and pulses less than 3.8 x 10 to the power of negative 4 seconds (1040.11(b)).</p><p><b>Demonstration laser product</b> means any laser product manufactured, designed, intended, or promoted for purposes of demonstration, entertainment, advertising display, or artistic composition. The term "demonstration laser product" does not apply to laser products which are not manufactured, designed, intended, or promoted for such purposes, even though they may be used for those purposes or are intended to demonstrate other applications. Demonstration laser products (1040.10(b)(13)) include:</p><p style="margin-right: 0.0; margin-left: 20.0; text-indent: 0.0" align="left">laser products promoted for classroom demonstration of optical phenomena;</p><p style="margin-right: 0.0; margin-left: 20.0; text-indent: 0.0" align="left">artistic displays and their associated apparatus;</p><p style="margin-right: 0.0; margin-left: 20.0; text-indent: 0.0" align="left">laser light show projectors; and</p><p style="margin-right: 0.0; margin-left: 20.0; text-indent: 0.0" align="left">laser light shows and displays themselves.</p><p>A general-purpose, scientific, medical or industrial laser product is not considered to be a demonstration laser product when it is demonstrated to a prospective purchaser. Demonstration laser products are restricted in their outputs to Class IIIa with its accompanying restrictions to Class I for short pulses and invisible wavelengths(1040.11(c)). Because these levels are too low for effective use in commercial theatrical lighting effects, CDRH may grant variances (1010.4) to manufacturers of laser light shows and display devices. As a condition of the variance, the manufacturer must agree to adhere to several safety conditions to provide a level of safety to the public equivalent to a fully compliant product. Consult the Compliance Guide for Laser Products, September 1985, Appendix B, Clarification of Certain Laser Light Show Requirements, for more information.</p></body></html>
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<font face="arial,helvetica,georgia,verdana" size="2">PART 2: PRODUCT AND MODEL IDENTIFICATION</font>
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<html><body><table border=1 cellpadding=10 width=100% bgcolor="#FFFFDE"> <td><h1 align="Center"><font color="#0000FF"><strong>!  Attention  !</strong></font></h1><br> <font color=red>  <p style="font-family:tahoma;font-size:100%" align="Left"><strong>
In the following sections of the report template you will see references to "Laser Notice #NN" and the "Compliance Guide for Laser Products.'"  You can find these documents and other information relating to laser products on the page <b><a href="http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/LaserProductsandInstruments/default.htm"><i>Laser Products and Instruments</i></a></b>.<br>
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On the Laser Products page you can click on the button link at the top, right side of the page <b><a href="http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/LaserProductsandInstruments/ucm116422.htm"><i>Notices to the Laser Industry</i></a></b> and you will be taken to the page which lists links to the Laser Notices and the Compliance Guide for Laser Products sorted in date order.<br>
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The Compliance Guide itself may be found at this link: <b><a href="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095304.pdf"><i>Compliance Guide for Laser Products (FDA 86-8260)</i></a></b><br>
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<font face="arial,helvetica,georgia,verdana" size="2">2.1 Model Designation</font>
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<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
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<font face="arial,helvetica,georgia,verdana" size="1"><i>Report the model name and/or number, model family, brand name, or other designation of the product.  If reporting a model family, provide the model designation of each model.  If you do not use a model family or brand name, leave the field blank.</i></font>
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<font face="arial,helvetica,georgia,verdana" size="1">Model Designation (Names and/or Numbers):</font>
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<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Item</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Model Name</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Family Name</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Brand Name</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Item 1</font>
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<font face="arial,helvetica,georgia,verdana" size="1">ParticleView V19</font>
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<font face="arial,helvetica,georgia,verdana" size="1"> </font>
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<font face="arial,helvetica,georgia,verdana" size="1"> </font>
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<font face="arial,helvetica,georgia,verdana" size="2">2.2 Approval of Alternate Means</font>
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<font face="arial,helvetica,georgia,verdana" size="1"><b>Does this document or any of its attachments contain:</b></font>
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<font face="arial,helvetica,georgia,verdana" size="1">An application for approval of alternate means of providing the equivalent or superior protection that a required performance feature or labeling would provide (this is applicable to the beam attenuator requirements and alternate labeling)?</font>
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<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Yes</font>
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<font face="arial,helvetica,georgia,verdana" size="1">What requirement are you requesting an approval of alternate means from?</font>
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<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Certification label</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Provide an explanation:</font>
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<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Area for labeling is too small on the product. Label will be part of the Safety Manual for the product.</font>
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<font face="arial,helvetica,georgia,verdana" size="2">2.3 Product without a Laser</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Is it a product that does not incorporate a laser but is intended to incorporate a laser?</font>
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<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<font face="arial,helvetica,georgia,verdana" size="1">No</font>
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<font face="arial,helvetica,georgia,verdana" size="1">If the product as introduced into commerce does not incorporate a laser, identify the manufacturer and models of the laser that you recommend:</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Item</font>
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<font face="arial,helvetica,georgia,verdana" size="1"> </font>
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<font face="arial,helvetica,georgia,verdana" size="1">Is it a product that is intended to be used with a laser?</font>
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<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<font face="arial,helvetica,georgia,verdana" size="1">No</font>
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<font face="arial,helvetica,georgia,verdana" size="1">If the product as introduced into commerce is intended to be used with a laser, identify the manufacturer and models of the laser that you recommend:</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Item</font>
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<font face="arial,helvetica,georgia,verdana" size="1"> </font>
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<font face="arial,helvetica,georgia,verdana" size="1">If your product does not incorporate a laser or you do not recommend a specific laser for use with the reported product, state the specifications of the laser or laser system which may beincorporated in or used with your product.  This would include wavelengths, power or energy levels, etc.</font>
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<font face="arial,helvetica,georgia,verdana" size="1"> </font>
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<font face="arial,helvetica,georgia,verdana" size="2">2.4 Modification of a Laser Product</font>
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<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
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<font face="arial,helvetica,georgia,verdana" size="1"><i>Modification involves any changes to the product that affect its classification, performance or labeling requirements (as required by the standard or an approved variance).</i></font>
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<font face="arial,helvetica,georgia,verdana" size="1">Is your laser product the result of the modification of a laser product certified by another manufacturer?</font>
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<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<font face="arial,helvetica,georgia,verdana" size="1">No</font>
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<font face="arial,helvetica,georgia,verdana" size="2">2.5 Incorporation of Unmodified, Certified Laser Product</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Does your laser product incorporate an unmodified, certified laser product?</font>
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<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<font face="arial,helvetica,georgia,verdana" size="1">No</font>
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<font face="arial,helvetica,georgia,verdana" size="2">2.6 Incorporation of Uncertified Laser Product</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Does your laser product incorporate an uncertified laser product as a component or component subsystem?</font>
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<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Yes</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">2.6.1 Other Manufacturers</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><b>Item: 1</b></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Give the name and address and/or firm establishment registration number of the other manufacturer:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Laser Diodes, Inc., 4 Olsen Avenue, Edison, New Jersey 08820</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Identify the other manufacturer's model(s) and brand name(s):</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="8%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Item 1</font>
</td>
<td width="92%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Model CVD4S5000METR</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="50%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Provide the other manufacturer's accession number, if known:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">unknown</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Show how your model designations and brand names correspond with the other brand names and model designations listed:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No other designations</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">2.7 Incorporation of Removable Laser System</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does your laser product incorporate a removable laser system or systems as defined by 21 CFR 1040.10(c)(2)?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
</tr>
</table>
<p style="page-break-before: always"></p>
<table border="1" bordercolor="black" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="3"><b>Technical Data</b></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2"></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">PART 3: DESCRIPTION OF THE PRODUCT</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>In this section, you are asked to provide descriptions of the product, its intended function, and the laser radiation fields or paths and collateral radiation that may be accessible in operation, maintenance, or service modes of the product.  This section was previously Part 5 of the product reporting guide.</i></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">3.1 Product Description and Function</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>You may refer to brochures and manuals submitted as attachments to this report.</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe the product and its function:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\MK-PB-0113-AC ParticleView V19 Safety Manual.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">ParticleView V19 Safety Manual</a></font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Details</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><html>
  <head>

  </head>
  <body>
    <p style="margin-top: 0">
      The ParticleView V19 is an in-situ microscope. It is designed to acquire 
      microscope images directly inside a fluid medium. A video camera and 
      microscope optics are mounted inside a metal probe body. The fluid 
      medium is viewed through a sapphire probe window at the distal end of 
      the probe. The illumination system is housed inside a metal enclosure 
      mounted to the proximal end of the probe. The Introduction section of 
      the attached Safety Manual provides a more in-depth description.
    </p>
  </body>
</html></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">3.2 External and Internal Laser Radiation Fields and Paths</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Include beam path diagrams indicating protective housing, beam attenuators, viewports, scanners, targets, etc. Indicate energy and power levels at locations inside and outside the product.</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe the external and internal laser radiation fields and paths:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">The ParticleView V19 uses an illumination system comprising eight laser diodes, each permanently coupled to a multimode optical fiber. Each of the laser diodes is enclosed in a metal housing, no collateral radiation is emitted at this point. A gradient index lens is used to focus the light emitted from the multimode fiber through a sapphire probe window on to the field of view, the diameter being 1.5mm. Each beam is tilted with respect to the probe axis. Under normal operating conditions the operator is never exposed to light from the instrument. If an operator could turn the instrument to look straight in the probe, the eye will not be exposed to light from more than one beam at a time. The image is observed by a digital camera; there is no viewport for direct observation.</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">3.3 Operational Procedures and Accessible Radiation</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Describe here the procedures used during operation and the laser or collateral radiation that is accessible during these procedures.</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">List the procedures performed during operation:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">The user is advised about the intended use of the instrument (see attached User Manual). Under normal operating conditions the probe is inserted into a vessel containing a liquid. The operator could only be exposed to light scattered from individual particles present in the liquid. The light scattered by the particles would be several orders of magnitude lower than those of the illumination fields as discussed in Section 6. <br><br><br>The instrument is operated from a Personal Computer; all functions of the instrument are controlled by software. The software allows the operator to choose the intensity levels of each one of the eight illumination lasers individually to a maximum as specified in Section 6. The pulse repetition rate is software controlled up to a maximum rate of 15 pulses per second. It is not possible by use of software commands to exceed the intensity levels as described in Section 6.<br><br><br>No other laser or collateral radiation fields are emitted from the probe.</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Do these procedures provide human access to ANY laser or collateral radiation?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Do the levels of laser or collateral radiation exceed the limits of Class I or Table VI?</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Indicate those collateral and laser radiation fields to which human access is possible during those operation procedures. Include the locations and identifications of laser and collateral radiation made accessible by viewing optics, viewports, and display screens:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">3.4 Maintenance Procedures and Accessible Radiation</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Describe here the procedures used during maintenance and the laser or collateral radiation that is accessible during these procedures.</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">List the procedures performed during maintenance:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">The ParticleView V19 requires no maintenance that would affect the radiation levels as described in Section 6. <br><br><br>The operator is informed in the user manual that no user serviceable parts are inside the enclosure or probe.</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Do these procedures provide human access to laser or collateral radiation levels in excess of Class I or Table VI?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Indicate those collateral and laser radiation fields to which human access is possible during those maintenance procedures:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">3.5 Service Procedures and Accessible Radiation</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Describe here the procedures used during service and the laser or collateral radiation that is accessible during these procedures.</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">List the procedures performed during service:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">The ParticleView V19 instrument requires no regular service. If the probe has to be removed from the enclosure no radiation other than listed in Section 6 is emitted.</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Do these procedures provide human access to laser or collateral radiation levels in excess of Class I or Table VI?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Indicate those collateral and laser radiation fields to which human access is possible during those service procedures:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">PART 4: CERTIFICATION, CLASSIFICATION, AND LEVELS OF RADIATION</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>This section, covers the description of the certification and identification labels and the detailed explanation of your classification of the product.</i></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">4.1 Performance Standard Identification</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="16%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">With which performance standard does your product comply?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">IEC 60825-1 and/or 60601-2-22 Standards</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">4.2 Certification Label</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Required by the CDRH standard and Laser Notice #50 for all laser products regardless of whether the CDRH laser standard or the IEC laser standard is being used for other requirements..</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Is a certification label present on your product?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does your certification label state that the product complies with the FDA performance standards except for deviations pursuant to Laser Notice #50, dated July 24, 2007?</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Yes</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Attach a copy of the certification label with an indication of its location on the product:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Certification Label is located in the Safety Manual. A copy of the manual is attached.</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\MK-PB-0113-AC ParticleView V19 Safety Manual.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">ParticleView V19 Safety Manual</a></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">4.3 Identification Label</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Required on all laser products.</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Attach a copy of the identification label with an indication of its location on the product:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">The identification label is located on the probe interface unit. See drawing attached.</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\Attachment 3.2\14546575 Product Label.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">V19 Product Label</a></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">4.4 Performance Standard Classification</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="16%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Under which laser product performance standard are you classifying your product?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">IEC 60825-1</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">4.5 Laser Product Class</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="80%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Indicate the Class of the Laser Product:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Class 1</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">4.6 Operation</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>For classification purposes describe the radiation levels accessible in any of the operational configurations of the product.</i></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">4.7 Embedded Laser System</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Describe here laser radiation fields contained within the protective housing of the product which may exceed the class of the product. The classification of the contained laser radiation is pertinent to safety interlock and protective housing label requirements.</i></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">4.7.1 Internal Radiation Levels</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does the protective housing contain radiation in excess of the Class of the product (such as in a product that has a higher class laser embedded inside, such as a laser printer or workstation)?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">4.8 Maintenance</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Describe here the laser radiation fields accessible in maintenance configurations of the laser product.</i></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">4.9 Service</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Describe here the laser radiation fields accessible in service configurations of the laser product.</i></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">4.10 Collateral Radiation</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe all collateral radiation fields associated with the product.  Report the source(s) and levels and describe where and under what circumstances such radiation is accessible:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Product testing according to IEC 60825-1, 2nd Ed. was carried out as part of CB scheme compliance measurement. Report Ref. No. DI401990-000 is attached as reference. The product was classified as Class I. The measured emission power was less then 5% of the allowable class I limit.</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Provide a diagram of yourmeasurement set-up or the analysis used in your calculations. Provide pertinent dimensions such as separation distances, source and detectoraperture size, etc. to show compliance with the standard under which you are classifying:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\DI1401990_CB Report.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">IEC 60825 Report</a></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">PART 5: COMPLIANCE WITH PERFORMANCE REQUIREMENTS</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>In this section, you will describe how your product complies with the performance requirements. This section was previously Part 7 of the product reports.</i></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">5.1 Protective Housing</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Required for all classes of laser products (see 1040.10(f)(1) and Compliance Guide).</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe the product's protective housing and how it serves to prevent unnecessary human access to levels of laser radiation in excess of Class I:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">The laser diodes, fibers and optical components are protected inside an aluminum housing attached to a steel probe. Laser radiation exits the probe only from the sapphire window as described in Section 6.1. The housing is screwed together and cannot be disassembled without special tools. <br><br><br>The user is informed that no user serviceable parts are located inside the probe housing and that opening or removing the probe housing will void the warranty.<br><br><br>The laser diodes are permanently coupled to optical fibers, no collateral radiation is emitted even if the protective housing was removed.</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe how the protective housing prevents access to unnecessary collateral radiation in excess of Table VI:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">The laser diodes, fibers and optical components are protected inside an aluminum housing attached to a steel probe. Laser radiation exits the probe only from the sapphire window as described in Section 6.1. The housing is screwed together and cannot be disassembled without special tools. <br><br><br>The user is informed that no user serviceable parts are located inside the probe housing and that opening or removing the probe housing will void the warranty.<br><br><br>The laser diodes are permanently coupled to optical fibers, no collateral radiation is emitted even if the protective housing was removed.</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">5.2 Safety Interlocks</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Applicable for all Classes of laser products (see 1040.10(f)(2)(i) and Compliance Guide).</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><b>Does your product have portions of the protective housing that are intended to be opened or removed for:</b></font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="80%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Operation:</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="80%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Maintenance:</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="80%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Service:</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="80%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does your laser product incorporate any safety interlocks?</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Not Applicable</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">What types of interlocks (select all that apply):</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="8%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Item</font>
</td>
<td width="92%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">If other, then please specify:</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Provide an electrical block diagram illustrating the logic of all interlock systems:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Provide a detailed mechanical diagram showing where they all are located on the product:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">5.3 Remote Interlock Connector</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Applicable to Class IIIb or IV (and IEC:3B and 4) laser systems (see 1040.10(f)(3) and Compliance Guide).</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="72%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does the product have a remote interlock connector that disables the laser radiation when the circuit is open?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Not Applicable</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe the electrical and mechanical construction and operation of the remote connector (give its circuit and physical location):</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Record the open-circuit electrical potential difference between the terminals of the remote interlock connector:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">5.4 Security Master (Key) Control</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Required for Class IIIb or IV (and IEC:3B or 4) laser systems (see 1040.10(f)(4) and Compliance Guide).</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="52%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does your product have a Security Master control?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Not Applicable</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="52%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">What type of security control is it?</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="52%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">If other, then please specify:</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe how it works,including how the key control prevents unauthorized use of the product:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="52%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Is the key control removable in the "On" position?</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe the function of the key control and how it renders the laser inoperable when the "key" is removed:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">5.5 Laser Radiation Emission Indicator</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Required for Class II, IIIa, IIIb, or IV (and IEC: 3R, 3B, and 4) laser systems (see 1040.10(f)(5) andCompliance Guide).</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="68%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does the product incorporate any emission indicators?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Not Applicable</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe in detail the mechanical and electrical characteristicsof all emission indicators installed pursuant to Section 1040.10(f)(5)(i) or (ii) and give their locations:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="68%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">What type of emission indicator is incorporated?</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">If "other", please describe:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">How is your emission indicator warning fail-safe or redundant?</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">5.6 Beam Attenuator</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Required for Class II, IIIa, IIIb or IV (and IEC: 3B or 4) laser systems (see 1040.10(f)(6) and Compliance Guide).</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>You may be able to use currently approved alternate means or you may need to apply for approval of alternate means of providing this protection if this alternate means provides protection equivalent to a beam attenuator.</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="80%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does your product have a beam attenuator?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Not Applicable</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="80%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does your product have an alternative?</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe or attach request for approval of alternate means:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">5.7 Location of Controls</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Applicable to Class II, IIIa, IIIb or IV laser products (see 1040.10(f)(7) and Compliance Guide).</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Are operational and adjustment controls located so that exposure to laser radiation, above the accessible emission limits of Class I and Table VI, is unnecessary?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Yes</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Not applicable - Class 1 laser</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">5.8 Viewing Optics</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Applicable to all laser products (see 1040.10(f)(8)and Compliance Guide).</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="74%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does the product incorporate any of the following viewing optics:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">None</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">If so, please further describe the viewing optic that is incorporated:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="74%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Is the laser and collateral radiation that is accessible by virtue of viewing optics, viewports, or display screens less than the accessible emission limits of Class I and Table VI during operation and maintenance?</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Provide calculations and/or measurements,including pertinent attenuation factors, window transmission characteristics, etc.:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">5.9 Scanning Safeguard</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Required for certain laser products with scanned laser radiation (see 1040.10(f)(9) and Compliance Guide).</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>A safeguard is required when scan failure would cause the product to exceed the emission limits of its class.</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="70%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does the product incorporate a scanning safeguard?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Not Applicable</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe the mechanical, electrical, and functional characteristics of any required scan failure safeguard:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="70%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Is the classification of the product based on the level of scanned radiation?</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="70%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">What is the reaction time?</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Provide calculations to show that the safeguard's reaction time is adequate to prevent human access to laser radiation in excess of the product's class:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">5.10 Manual Reset</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Applicable to Class IV laser systems manufactured after August 20, 1986. (see 1040.10(f)(10) and Compliance Guide).</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does the product incorporate a manual reset mechanism or means that prevents automatic restart following interruptionof emission caused by power failure of at least 5 seconds or deactivationthrough the remote interlock connector?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Provide the circuit and physical description and location of the manual reset mechanism:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Class 1 laser</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does emission delay reactivate when power is resumed after an interruption of 5 seconds or more?</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Must the emission be manually restarted following interruption via the remote interlock connector?</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">5.11 Medical Laser Product</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Applicable to Class III or IV (and IEC: 3B or 4) medical laser products intended for in-vivo surgical, therapeutic, or diagnostic irradiation of the human body (see 1040.11(a) and Compliance Guide).</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
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<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>The requirement in section 1040.11(a) does not apply to visible aiming beams less than the accessible emission limits of Class IIIa except for ophthalmic indications.</i></font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe the means incorporated into the product to measure the level of laser radiation intended for irradiating the human body; include circuit diagrams and/or optical system diagrams:</font>
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<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<font face="arial,helvetica,georgia,verdana" size="2">5.11.1 Laser Radiation Levels</font>
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<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<font face="arial,helvetica,georgia,verdana" size="1">Is the radiation level continuously monitored?</font>
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<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Explain how the radiation level is monitored:</font>
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<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe how the system can assure the accuracy of the displayed value to within 20%:</font>
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<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<font face="arial,helvetica,georgia,verdana" size="2">5.11.2 Measurement and Monitoring Uncertainties</font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Specify the uncertainty in the measurement system and describe the method by which it was derived:</font>
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<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Specify the uncertainty in the monitoring system and describe the method by which it was derived:</font>
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<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe how the displayed power/energy level is either measured at the point of delivery or measured earlier and then the actual output calculated:</font>
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<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">If the displayed level is calculated, then provide calculations incorporating system constants, losses, attenuation factors, etc. to demonstrate accurate calibration of the delivered beam to +/-20%:</font>
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<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
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<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">5.11.3 Calibration Procedures</font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>A procedure for calibration of the means for output measurement is required by the CDRH laser standard.  However, if your medical laser product complies with IEC 60601-2-22 and you prefer to certify following Laser Notice #50, the IEC standard requires instructions for a calibration verification of the output beam.</i></font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Are procedures and a schedule for recalibration of the measurement system included in the user instructions?  If you are using the IEC 60601-2-22 standard for medical laser products in accordance with Laser Notice 50, do you provide instructions for doing a calibration verification of the output beam?</font>
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<font face="arial,helvetica,georgia,verdana" size="1">No</font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Identify location in the user instructions:</font>
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<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Not a medical laser product</font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">5.12 Surveying, Leveling, or Alignment Laser Products</font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>As a surveying, leveling, or alignment laser product it is subject to the requirements of section 1040.11(b).</i></font>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>If the product's class exceeds CDRH Class IIIa or IEC Class 3R or is IEC Class 1M or 2M, then an approved variance from the performance requirements in this section would be necessary prior to introduction into commerce.</i></font>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Is a variance request being submitted with this report?</font>
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<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">5.13 Demonstration Laser Products</font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>As a demonstration laser product it is subject to the requirements of section1040.11(c).</i></font>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>If the product's class exceeds CDRH Class IIIa or IEC Class 3R or is IEC Class 1M or 2M, then an approved variance from the performance requirements in this section would be necessary prior to introduction into commerce.</i></font>
</td>
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</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>An Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show,Display, or Device (form FDA 3147) must be submitted, following the instructions on the form.  A Laser Light Show Report may also be required for Class IIIb or IV shows or displays.</i></font>
</td>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>You may prepare all these reports and the variance request together using eSubmitter and transfer them all to a single CD to ship to CDRH, if that's the preferred method of submitting.  If you do this you need to remember that during packaging of each submission you must print and sign each submittal letter, then send each letter (either scanned & attached following the packaging instructions or just inserted into the envelope with the CD).</i></font>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="76%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Is a Laser Light Show report being submitted along with this report?</font>
</td>
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</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
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</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="76%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Is a variance application for a laser light show projector and laser light show being submitted along with this report?</font>
</td>
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</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="76%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does its user instructions include a warning not to direct the laser radiation at the audience?</font>
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<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">PART 6: COMPLIANCE WITH LABELING REQUIREMENTS</font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>In this section, you will describe how your product complies with the labeling requirements. This section was previously Part 3 of the product reporting guide.</i></font>
</td>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>For each of the following labels required for the product being reported, provide a sample or a facsimile of each label. Clearly indicate the locations on the product of allrequired labels. Submitting diagrams, photographs, blueprints, product literature, etc. is acceptable (see laser notices # 16, 17, 45, and 50).</i></font>
</td>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">6.1 Performance Standard Identification</font>
</td>
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</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="16%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">With which performance standard do your product's labels comply:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
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</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">IEC 60825-1 and/or 60601-2-22 Standards</font>
</td>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">6.2 Warning Logotype Label</font>
</td>
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</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Required on Class II, III, and IV laser products. (see 1040.10(g)(1), (2),(3),(4),(8),(9),(10) and Compliance Guide).</i></font>
</td>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Attach a copy with an indication of its location on the product:</font>
</td>
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</table>
</td>
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<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Class 1 laser</font>
</td>
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<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">6.3 IEC Warning Label</font>
</td>
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</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Required on all Class 1, 1M,2, 2M, 3R, 3B, and 4 laser products.</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Attach copies of both the warning label (hazard symbol) and the explanatory label with an indication of their locations on the product.  If the radiation output and the standard used are not stated on the explanatory label, then a copy of the label giving this information and its location on the product must also be attached.</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Area for labeling on the product is too small. Warning label is provided in the Safety Manual - attached.</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\MK-PB-0113-AC ParticleView V19 Safety Manual.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">ParticleView V19 Safety Manual</a></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">6.4 Class IIa Warning Label</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Required on Class IIa laser products (see 1040.10(g)(1)(i) and Compliance Guide).</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Attach a copy with an indication of its location on the product:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">6.5 Aperture Label</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Required on Class II, III and IV (IEC: 3R, 3B, and 4) laser products (for nonmedical laser products see 1040.10(g)(5),(8),(9),(10) or for medical laser products see 1040.11(a)(3) and Compliance Guide).</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Attach a copy with an indication of its location on the product:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">6.6 Protective Housing Labels</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>See 1040.10(g)(6),(7),(8),(9),(10), Compliance Guide, and Laser Notice 17.</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="72%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does your product have any protective housing labels?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Not Applicable</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does your product have any noninterlocked protective housing labels?</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Attach a copy with an indication of its location on the product:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Indicate how the label(s) are visible both prior to and during opening or removal of housing:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does your product have any defeatably interlocked protective housing labels?</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Attach a copy with an indication of its location on the product:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Indicate how the label(s) are visible both prior to and during interlock defeat:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does your product have any optionally interlocked protective housing labels?</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Attach a copy with an indication of its location on the product:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Indicate how the labels are visible both prior to and during opening or removal of the housing:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">PART 7: COMPLIANCE WITH INFORMATIONAL REQUIREMENTS</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>In this section, you will describe how your product complies with the informational requirements. This section was previously Part 4 of the product reporting guide.</i></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">7.1 User Information</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Submit a copy of user information (operator's manuals) for your laser product. If the manual is very extensive, submit those portions that confirm compliance with Section 1040.10(h) [and 1040.11(a)(2), if a medical laser product]:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Safety Manual</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\MK-PB-0113-AC ParticleView V19 Safety Manual.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">ParticleView V19 Safety Manual</a></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="76%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does the manual contain adequate instructions for assembly, operation, and maintenance?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Yes</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="76%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does it contain clear warnings to avoid exposure?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Yes</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="76%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does it contain a statement of output parameters?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Yes</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="76%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does it contain legiblereproductions of all labels, their locations on the product, and hazard warnings?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Yes</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="76%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does it contain a listing of controls, adjustments, and procedures for operation and maintenance?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Not Applicable</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="76%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does it contain a schedule of maintenance?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Yes</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="76%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does it contain the "Caution - use of controls..." warning statement?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Not Applicable</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="76%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does it include information to determine nominal hazard zone for users?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Not Applicable</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="76%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does it contain a compatibility statement concerning recommended lasers or specifications?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Not Applicable</font>
</td>
</tr>
</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="76%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Does it contain an additional warning stating that viewing the laser output with optical instruments may result in an eye hazard for Class 1M or an increased hazard for Class 2M?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Not Applicable</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>These materials may also have been used in the product description required by Part 3.</i></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">7.2 Promotional Literature</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Submit copies of any sales literature, including catalogs, specification sheets, and descriptive brochures for Class IIa, II, III, and IV laser products:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Not Applicable - class 1 laser</font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>This material is needed to demonstrate compliance with Section 1040.10(h)(2), which states that a reproduction of the warning logotype is required in all catalogs, specification sheets, and descriptive brochures.</i></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">7.3 Servicing Information</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Submit a copy of the relevant radiation safety sections of your product's servicing information (from your service manual):</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Safety Manual attached</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\MK-PB-0113-AC ParticleView V19 Safety Manual.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">ParticleView V19 Safety Manual</a></font>
</td>
</tr>
</table>
<p style="page-break-before: always"></p>
<table border="1" bordercolor="black" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="3"><b>Quality Control</b></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2"></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">PART 8: PRODUCT DESIGN VERIFICATION</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>In this section, any attached files must identify the manufacturing facility and name of the responsible Quality Assurance manager for the activity.  This section waspreviously Part 9 of the laser product reporting guide.<br>In this section, you will also describe those design considerations, verification activities, and controls implemented to ensure that the reported product will remain in compliance with the Federal laser product performance standard during its useful life.<br>Quality control and product testing should be based on design considerations and factors that can affect product compliance with the Federal laser product performance standard.</i></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">8.1 Critical Design Requirements</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">List the factors identified during design that may provide product compliance with the Federal laser product performance standard or performance as related to accessible or emitted laser radiation (e.g. performance specifications, component selection):</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">None</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">8.2 Life Testing</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>In this section you will describe those verification activities conducted to assure product compliance with the Federal laser product performance standard over its useful life.</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Maintenance and/or service instructions must include schedules for maintenance and replacement of components that may be necessary for the compliance of the product during its useful life.</i></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Testing of features designed to meet Federal laser product performance requirements:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Testing Procedure PR-WI-0024-AC</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\Attachment 8.1\PR-WI-0024-AC ParticleView V19 Test Procedure.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">Test Procedure</a></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Acceptance of electrical and electronic components:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">QA-PC-0000-AC Quality Manual</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\Attachment 8.1\QA-PC-0000-AC Quality Manual.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">Quality Manual</a></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Dimensional stability and rigidity of mechanical parts and assemblies such as housings and mounts:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">QA-PC-0000-AC Quality Manual</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\Attachment 8.1\QA-PC-0000-AC Quality Manual.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">Quality Manual</a></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Environmental stability of components such as filter materials, coatings,and adhesives:</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">QA-PC-0000-AC Quality Manual</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\Attachment 8.1\QA-PC-0000-AC Quality Manual.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">Quality Manual</a></font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Other factors that might affect your product's radiation safety:</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="88%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Provide an estimate of the useful life of the product (in years):</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">15</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">8.3 Change Controls</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe the controls implemented to assure compliance with the Federal laser product performance standard (e.g. control of design changes, user and service information changes, labeling changes to assure that compliance of the product is not jeopardized.):</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
</tr>
</table>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">QA-PC-0000-AC Quality Manual</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\Attachment 8.1\QA-PC-0000-AC Quality Manual.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">Quality Manual</a></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">PART 9: QUALITY CONTROL TESTS AND PROCEDURES</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
</td>
<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>In this section, any attached files must identifythe manufacturing facility and name of the responsible Quality Assurance manager for the activity.  This section was previously Part 8 of the laser product reporting guide.<br>Section 1010.2(c) requires that certification be based on a test, in accordance with the standard, of each unit or on a program in accordance with good manufacturing practices.<br>Failure to maintain an adequate testing program may result in disapproval of the program by CDRH.</i></font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">9.1 Quality Control Documentation</font>
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<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
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<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Attach samples of documents that describe, specify, or relate to procedures or tests used to ensure compliance of your reported product with the standard, including compliance with all performance, labeling, and informational requirements.</i></font>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<font face="arial,helvetica,georgia,verdana" size="1">Specification controls for critical components:</font>
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<font face="arial,helvetica,georgia,verdana" size="1">QA-PC-0000-AC Quality Manual</font>
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<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
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<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\Attachment 8.1\QA-PC-0000-AC Quality Manual.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">Quality Manual</a></font>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Manufacturing and assembly control procedures:</font>
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<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">QA-PC-0000-AC Quality Manual</font>
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<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\Attachment 8.1\QA-PC-0000-AC Quality Manual.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">Quality Manual</a></font>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Inspection and test control procedures:</font>
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<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">QA-PC-0012-WA In-Process and Final Inspection Procedure</font>
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<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\Attachment 8.1\QA-PC-0012-WA In-Process and Final Inspection Procedure.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">In-Process and Final Inspection</a></font>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Assembly and test traveler forms:</font>
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<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Testing Procedure PR-WI-0024-AC</font>
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<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
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<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\Attachment 8.1\PR-WI-0024-AC ParticleView V19 Test Procedure.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">Test Procedure</a></font>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Inspection and test reports and checklists:</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Final Inspection QA-FM-0054-AC</font>
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<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
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<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\Attachment 8.1\QA-FM-0054-AC Final Inspection and Packing Checklist.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">Final Inspection Checklist</a></font>
</td>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Other(s), specify:</font>
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<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">9.2 Alternate Quality Control Procedures</font>
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<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">If formal quality control and testing procedures have not been implemented or are not sufficient to assure that your product(s) will comply with the standard, explain how you assure that your products comply and submit supporting documentation:</font>
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<font face="arial,helvetica,georgia,verdana" size="1"> </font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<font face="arial,helvetica,georgia,verdana" size="2">PART 10: INSTRUMENTATION AND CALIBRATION</font>
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<td width="15%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
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<td width="85%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>In this section, you will describe the instrumentation used for compliance testing your product and the instrumentation calibration procedures.</i></font>
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<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">10.1 Component Testing</font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Do you purchase components or services from contractors or original equipment manufacturers in lieu of conducting your own in-house testing?</font>
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<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
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</table>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Provide certificates or sample test/inspection records from suppliers or original equipment manufacturers, etc. to assure that those entities are operating in a state of control.</font>
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<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
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</table>
<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe those tests and controls used to determine whether the reported product is producedto be in compliance with the Federal laser product performance standard:</font>
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<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Do you conduct in-house compliance testing for your product?</font>
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<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Do you have testing done by an outside contractor?</font>
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<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<font face="arial,helvetica,georgia,verdana" size="2">10.2 Compliance Testing</font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe those tests and controls used to determine whether the reported product is produced to be in compliance with the Federal laser product performance standard:</font>
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<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<font face="arial,helvetica,georgia,verdana" size="1">ParticleView V19 Test Procedure</font>
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<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
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<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\Attachment 8.1\PR-WI-0024-AC ParticleView V19 Test Procedure.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">Test Procedure</a></font>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">List the instruments you use to determine compliance of the reported product with the standard.  Describe these instruments or provide copies of specification sheets.  Identify each detector's aperture size, if applicable.</font>
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<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Not applicable. Output powers are well below class 1 limits by design and verified by independent testing.</font>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Indicate how the measurement system collects or accounts for the total radiant energy or power specified in Section 1040.10(e):</font>
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<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Not applicable. Output powers are well below class 1 limits by design and verified by independent testing.</font>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Provide a measurement error analysis (for all sources of error identified) and an uncertainty statement for all measurement data reported. (If it isclear from the measurement data, including the total estimated uncertainty, that the levels are well below the applicable class limit, then an error analysis and uncertainty statement are not required.  For example, an error analysis and uncertainty statement would not be required for a 1.5 milliwattHeNe laser product classified in Class IIIa.):</font>
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<font face="arial,helvetica,georgia,verdana" size="1">Not applicable. Output powers are well below class 1 limits by design and verified by independent testing.</font>
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<font face="arial,helvetica,georgia,verdana" size="2">10.3 Calibration</font>
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<table border="0" cellspacing="0" cellpadding="0" width="100%">
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<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Provide instrument calibration schedules and indicate how your instruments are calibrated (e.g.,calibrated by your company against a working standard, returned to the manufacturer of the instrument, sent to an independent calibration laboratory)  [If your laser product operates at a level closely approaching a specified limit, high accuracy and traceabilty to the National Institute of Standards and Technology (previously known as the National Bureau of Standards) are important]:</font>
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<td width="100%" bgcolor="#FFFFFF" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Not applicable. Output powers are well below class 1 limits by design and verified by independent testing.</font>
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<p style="page-break-before: always"></p>
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<font face="arial,helvetica,georgia,verdana" size="3"><b>General Variance Request</b></font>
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<font face="arial,helvetica,georgia,verdana" size="2"></font>
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<font face="arial,helvetica,georgia,verdana" size="2">Intended Use and Variance Description</font>
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<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe the product and its intended use.</font>
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<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
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<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\MK-PB-0113-AC ParticleView V19 Safety Manual.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">ParticleView V19 Safety Manual</a></font>
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<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Details</font>
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<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><html>
  <head>
    
  </head>
  <body>
    <p>
      <a name="_GoBack">
</a><b>The ParticleView V19 is an in-situ microscope. It is designed to 
      acquire microscope images directly inside a fluid medium.  A video 
      camera and microscope optics are mounted inside a metal probe body. The 
      fluid medium is viewed through a sapphire probe window at the distal end 
      of the probe.  The illumination system is housed inside a metal 
      enclosure mounted to the proximal end of the probe. </b>
    </p>
    <p>
      <b>The Introduction section of the attached Safety Manual provides a 
      more in-depth description.</b>
    </p>
  </body>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
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<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Explain how compliance with the standard would restrict or be inappropriate for this intended use.  Please attach any additional information if necessary.</font>
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<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
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</table>
</td>
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<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\MK-PB-0113-AC ParticleView V19 Safety Manual.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">ParticleView V19 Safety Manual</a></font>
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<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Details</font>
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<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><html>
  <head>
    
  </head>
  <body>
    <p>
      The ParticleView V19 uses an illumination system comprising eight laser 
      diodes, each permanently coupled to a multimode optical fiber. Each of 
      the laser diodes is enclosed in a metal housing, no collateral radiation 
      is emitted at this point. A gradient index lens is used to focus the 
      light emitted from the multimode fiber through a sapphire probe window 
      on to the field of view, the diameter being 1.5mm. Each beam is tilted 
      with respect to the probe axis. Under normal operating conditions the 
      operator is never exposed to light from the instrument. If an operator 
      could turn the instrument to look straight in the probe, the eye will 
      not be exposed to light from more than one beam at a time. The image is 
      observed by a digital camera; there is no viewport for direct 
      observation. Information is given in the Safety Manaul -- see attached.
    </p>
  </body>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe the manner in which it is proposed to deviate from the requirements of the applicable standard.  Attach any supporting files if necessary.</font>
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<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
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</table>
</td>
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<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">File Attachment</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><a href="C:\Users\desormeaux-1\Desktop\FDA Submission\Attachment 3.2\14546575 Product Label.pdf" title="Note: File attachments may not be accessible if the report or attachment locations are changed">V19 Product Label</a></font>
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<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Details</font>
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<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><html>
  <head>

  </head>
  <body>
    <p style="margin-top: 0">
      The area for product labeling is too small. We will put the 
      certification label in the Safety Manual in the certifications chapter. 
      See attached drawing of the current product label which is too small for 
      the certification information.
    </p>
  </body>
</html></font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td align="right" width="4%" bgcolor="#F5F5F5" colspan="1" rowspan="3">
<font face="arial,helvetica,georgia,verdana" size="3"><b>» </b></font>
</td>
<td width="96%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Describe the advantages to be derived from such deviation.</font>
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<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Details</font>
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<td width="76%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><html>
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  </head>
  <body>
    <p style="margin-top: 0">
      Important information regarding laser safety and certification will be 
      placed with other certification statements in the safety manual. This 
      will alert the user to all certifications.
    </p>
  </body>
</html></font>
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<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">Radiation Protection and Variance Duration</font>
</td>
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<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Provide a detailed explanation of how alternate or suitable means of radiation protection will be provided.  Click on the Add... button below to attach any supporting files.</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
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</td>
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<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Details</font>
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<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><html>
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    <p style="margin-top: 0">
      not applicable
    </p>
  </body>
</html></font>
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<hr size="1"></hr>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="72%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Provide the period of time it is desired that the variance be in effect.</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
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<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Other...</font>
</td>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="72%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">If "Other" has been selected, please specify further.</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
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<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">not applicable</font>
</td>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="72%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">If appropriate, provide the number of units the applicant plans to manufacture.</font>
</td>
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<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
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<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">Prototype or Experimental Design</font>
</td>
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<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Is the product a prototype or experimental design?</font>
</td>
<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
</td>
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<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">No</font>
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<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Remarks</font>
</td>
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<td width="100%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
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<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">Certification</font>
</td>
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<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="94%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="95%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">The manufacturer certifies the following:<br><br>All of the above information and statements are true, complete, and correct to the best of my knowledge.  The manufacturer acknowledges that the variance application may be denied or the variance may be revoked if this application is found to be false, misleading or incorrect in any material way.  The manufacturer has submitted and will submit all reports required by 21 CFR Part 1002.  The manufacturer further understands that they may be required by regulation or by the Director, Center for Devices and Radiological Health, to supply such other information as may be necessary to evaluate and act on this application.</font>
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<td align="right" width="5%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">*</font>
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<td width="25%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Yes</font>
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<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<table border="0" cellspacing="0" cellpadding="0" width="100%">
<tr align="left" valign="top">
<td width="100%" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Copy from the contact address book.</font>
</td>
</tr>
</table>
</td>
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<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Contact Information:</i></font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Contact Name</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Brenda Desormeaux</font>
</td>
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<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Occupation Title</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Quality Manager</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Email Address</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">brenda.desormeaux@mt.com</font>
</td>
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<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Establishment Information:</i></font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Establishment Name</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Mettler-Toledo AutoChem</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Division Name</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
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<tr align="left" valign="top">
<td width="35%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">FDA Establishment Identifier (FEI)</font>
</td>
<td width="65%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
<tr align="left" valign="top">
<td width="35%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Central File Number (CFN)</font>
</td>
<td width="65%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
<tr align="left" valign="top">
<td width="35%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Registration Number</font>
</td>
<td width="65%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
<tr align="left" valign="top">
<td width="35%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Owner/Operator Number</font>
</td>
<td width="65%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
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<tr align="left" valign="top">
<td width="35%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">D&B D-U-N-S Number</font>
</td>
<td width="65%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Physical Location:</i></font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Address</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">7075 Samuel Morse Drive<br>Suite 100<br>Columbia, MD, 21046, US</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Telephone Number</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">(410) 910-8100</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Fax Number</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
<tr align="left" valign="top">
<td width="100%" bgcolor="#F5F5F5" colspan="2" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"><i>Mailing Location:</i></font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Address</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">7075 Samuel Morse Drive<br>Suite 100<br>Columbia, MD, 21046, US</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Telephone Number</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">(410) 910-8100</font>
</td>
</tr>
<tr align="left" valign="top">
<td width="20%" bgcolor="#F5F5F5" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1">Fax Number</font>
</td>
<td width="80%" bgcolor="#FFFFFF" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="1"> </font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="middle">
<td width="100%" bgcolor="#D0D0D0" colspan="1" rowspan="1">
<font face="arial,helvetica,georgia,verdana" size="2">Packaging Instructions</font>
</td>
</tr>
</table>
<br>
<table border="1" bordercolor="#8E8E8E" cellspacing="0" cellpadding="3" width="100%">
<tr align="left" valign="top">
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<font face="arial,helvetica,georgia,verdana" size="1"><i>Stop:</i></font>
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<font face="arial,helvetica,georgia,verdana" size="1"><i>For all Variance requests, two submissions must be made to the FDA.  <br><br>The electronic version should be submitted following the Packaging Files for Submission instructions located under Output in the Menu bar, and explained in subsection 4.3 of the User Manual.  If sending a CD & submittal letter, please mail to: <br><br>Center for Devices and Radiological Health<br>Attn: eSubmitter Team<br>Document Mail Center - WO66-G609<br>10903 New Hampshire Ave<br>Silver Spring, MD 20993-0002<br><br>Additionally, a paper version (hard-copy) of the signed Variance request document should be submitted to:<br><br>Food and Drug Administration<br>Division of Dockets Management (HFA-305)<br>5630 Fishers Lane, Room 1061<br>Rockville, MD 20852</i></font>
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<font face="arial,helvetica,georgia,verdana" size="1"><i>Note:</i></font>
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<font face="arial,helvetica,georgia,verdana" size="1"><i>In a few weeks you should receive a Docket number from Dockets Management and a Variance number from CDRH.  Both of these numbers may be saved with this report in the following procedure:<br><br>1. Reopen this report<br>2. Click on the File Menu and select Properties<br>3. In the Comments field, you may enter these identifying numbers and any other pertinent information for future reference.</i></font>
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<font face="arial,helvetica,georgia,verdana" size="1"><i>Stop:</i></font>
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<font face="arial,helvetica,georgia,verdana" size="1"><i>You have reached the end of this report.  Please verify that all PDFs that are to be included in this submission are correctly attached to a specific file attachment question.  Otherwise, they will not be packaged with your report.  Check to make sure you have no missing data (select Missing Data Report from the Output menu). Once you have confirmed that there is no missing data and all your files are attached, click on the Package Submission icon on the tool bar.</i></font>
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