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<tr class="odd">
<td colspan="12">Form Approved: OMB No. 0910-0120; Expiration Date:
8/31/10</td>
</tr>
<tr class="even">
<td colspan="2"><blockquote>
<p>Department of Health and Human Services</p>
<p>Food and Drug Administration</p>
</blockquote>
<p>Center for Devices and Radiological Health</p></td>
<td colspan="10"><blockquote>
<p><strong>PREMARKET NOTIFICATION [510(K)] STATUS</strong></p>
</blockquote>
<p><strong>REQUEST AND RESPONSE</strong></p></td>
</tr>
<tr class="odd">
<td colspan="12"><blockquote>
<p><strong>Single Form –</strong> To be used for <em>both</em> your
request and FDA’s response. Requesters should fill in the information on
the top half of this form (Request Section) and fax (or mail) this form
to the FDA at the fax # or address listed below. The FDA will complete
the information on the bottom half (Response Section) and return by fax
(or mail).</p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="12"></td>
</tr>
<tr class="odd">
<td colspan="12"><blockquote>
<p><strong>REQUEST SECTION <em>(To be completed by
requester)</em></strong></p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="4" rowspan="7"><blockquote>
<p><em><strong>To (From)</strong></em></p>
<p>FDA, Center for Devices &amp; Radiological Health</p>
<p>Division of Small Manufacturers, International<br />
and Consumer Assistance (DSMICA)<br />
Attn: 510(k) Status Coordinator</p>
<p>1350 Piccard Drive (HFZ-220)</p>
<p>Rockville, MD 20850 USA</p>
<p>Fax Number: (240) 276-3151</p>
<p>Phone: (240) 276-3150 or</p>
</blockquote>
<p>(800) 638-2041</p></td>
<td colspan="7"><em><strong>From (To)</strong></em></td>
<td rowspan="7"></td>
</tr>
<tr class="odd">
<td colspan="7"><p>Requester Name</p>
<p>     </p></td>
</tr>
<tr class="even">
<td colspan="7"><p>Mailing Address</p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="7"><p>FAX Number</p>
<p>     </p></td>
</tr>
<tr class="even">
<td colspan="7"><p>Telephone Number</p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="7">Requester’s Affiliation with the submitter of<br />
the 510(k)      </td>
</tr>
<tr class="even">
<td colspan="7"></td>
</tr>
<tr class="odd">
<td colspan="12"><blockquote>
<p><strong>Requester Certification:</strong> I certify that I am an
authorized representative of the submitter of the following 510(k)<br />
and that all information provided herein is truthful to the best of my
knowledge. Please provide me with inform-<br />
ation related to the status of the following 510(k) submission via
<em>(mark one)</em>: FAX or MAIL </p>
</blockquote></td>
</tr>
<tr class="even">
<td></td>
<td colspan="10"></td>
<td></td>
</tr>
<tr class="odd">
<td rowspan="4"></td>
<td colspan="2"><p>510(K) Number</p>
<p>     </p></td>
<td colspan="8">Requester Signature</td>
<td rowspan="4"></td>
</tr>
<tr class="even">
<td colspan="4" rowspan="2"><p>Sponsor’s Name and Address</p>
<p>     </p></td>
<td colspan="6"><p>Product Name</p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="6"><p>Date logged in by FDA (ODE) <em>– as identified
in<br />
acknowledgement letter</em></p>
<p>     </p></td>
</tr>
<tr class="even">
<td colspan="10"></td>
</tr>
<tr class="odd">
<td colspan="12"></td>
</tr>
<tr class="even">
<td colspan="12"><blockquote>
<p><strong>RESPONSE SECTION <em>(To be completed by
FDA)</em></strong></p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="12"><blockquote>
<p><strong>NOTE: THIS DOCUMENT IS INTENDED ONLY FOR THE USE OF THE PARTY
TO WHOM IT IS ADDRESSED AND CONTAINS INFORMATION THAT IS PRIVILEGED,
CONFIDENTIAL, AND PROTECTED FROM DIS-CLOSURE UNDER APPLICABLE
LAW.</strong></p>
<p>If you are not the addressee, or authorized to deliver this document
to the addressee, you are hereby notified that review, disclosure,
dissemination, copying, or other action based on the content of this
communication is not<br />
authorized. If document has been received in error, please notify FDA by
phone and return via mail.</p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="8" rowspan="3"><blockquote>
<p><strong>Reviewing Branch:</strong> <u>     </u></p>
<p>Please be advised that the average total time (time for FDA review
plus time spent awaiting any additional data) for review of a device
assigned to this branch has been <u>     </u> days over the last 6
months.</p>
</blockquote></td>
<td rowspan="3"></td>
<td colspan="2"></td>
<td rowspan="3"></td>
</tr>
<tr class="odd">
<td colspan="2"><p>Last Action and Date</p>
<p>     </p></td>
</tr>
<tr class="even">
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="12"><blockquote>
<p><strong>Place in Queue:</strong> Your 510(k) has been assigned to a
reviewer and is # <u>     </u> in line for that reviewer to work on. The
length of time that it will take for the reviewer to get to your 510(k)
and to review it will depend on many<br />
factors, such as the complexity of the 510(k)’s that are in line ahead
of you, and other work assigned to the</p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="6" rowspan="4"><blockquote>
<p>reviewer, for example the review of investigational device exemption
submissions. Due to these variables, we cannot estimate a completion
date for review of your 510(k). However, future inquiries can give you
an idea of how your 510(k) is progressing.</p>
</blockquote></td>
<td rowspan="4"></td>
<td colspan="4"></td>
<td rowspan="4"></td>
</tr>
<tr class="odd">
<td colspan="4"><p>FDA Response Date <em>(Please do not request
another<br />
status report prior to 30 days from the FDA response date.)</em></p>
<p><strong>     </strong></p></td>
</tr>
<tr class="even">
<td colspan="4"><em>Please do not request another status report prior to
30 days from the FDA response date.</em></td>
</tr>
<tr class="odd">
<td colspan="4"></td>
</tr>
<tr class="even">
<td colspan="10"><strong>FORM FDA 3541 (9/07) Page 1</strong></td>
<td colspan="2">PSC Graphics: (301) 443-1090 EF</td>
</tr>
</tbody>
</table>

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|   | Public Reporting   |                                       |    |
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|   |                    | Food and Drug Administration          |    |
|   |                    |                                       |    |
|   |                    | Center for Devices & Radiological     |    |
|   |                    | Health                                |    |
|   |                    |                                       |    |
|   |                    | Division of Small Manufacturers,      |    |
|   |                    | International\                        |    |
|   |                    | and Consumer Assistance (DSMICA)\     |    |
|   |                    | 1350 Piccard Drive (HFZ-220)          |    |
|   |                    |                                       |    |
|   |                    | Rockville, MD 20850                   |    |
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