Document ID: FDA-2014-V-1913-0003
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-11-18T05:00Z

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<TITLE>Submittal Letter</TITLE>
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<font face="arial,helvetica,georgia,verdana" size="1">Mettler-Toledo AutoChem</font><br>
<font face="arial,helvetica,georgia,verdana" size="1">7075 Samuel Morse Drive</font><br>
<font face="arial,helvetica,georgia,verdana" size="1">Suite 100</font><br>
<font face="arial,helvetica,georgia,verdana" size="1">Columbia, MD, 21046, US</font><br>
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<font face="arial,helvetica,georgia,verdana" size="1">October 30, 2014</font><br>
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<font face="arial,helvetica,georgia,verdana" size="1">U.S. Food and Drug Administration</font><br>
<font face="arial,helvetica,georgia,verdana" size="1">Center for Devices and Radiological Health</font><br>
<font face="arial,helvetica,georgia,verdana" size="1">Attn: eSubmitter Team</font><br>
<font face="arial,helvetica,georgia,verdana" size="1">Document Mail Center - WO66-0609</font><br>
<font face="arial,helvetica,georgia,verdana" size="1">10903 New Hampshire Avenue</font><br>
<font face="arial,helvetica,georgia,verdana" size="1">Silver Spring, MD 20993-0002</font><br>
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<font face="arial,helvetica,georgia,verdana" size="1">Dear Sir or Madam:</font><br>
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<font face="arial,helvetica,georgia,verdana" size="1">This submission dated October 30, 2014, is filed pursuant to the regulations for the administration and enforcement of the Federal Food, Drug, and Cosmetic Act, Chapter V, Subchapter C, Electronic Product Radiation Control (Title 21, Code of Federal Regulations, Subchapter J, Parts 1000-1050). The submission is a(n) Variance Request (General, not Laser Light Show) (21 CFR 1010.4). These Laser - Research, Scientific, Laboratory Laser Products (REN) include designated model not associated with a model family: ParticleView V19.</font><br>
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<font face="arial,helvetica,georgia,verdana" size="1">This submission includes the following item(s) for special consideration:</font>
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<li><font face="arial,helvetica,georgia,verdana" size="1">This submission includes an application for a variance from certain requirements.</font></li>
<li><font face="arial,helvetica,georgia,verdana" size="1">Request for approval of alternate labeling</font></li>
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<font face="arial,helvetica,georgia,verdana" size="1">Sincerely,</font><br>
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<font face="arial,helvetica,georgia,verdana" size="1">Brenda Desormeaux</font><br>
<font face="arial,helvetica,georgia,verdana" size="1">Quality Manager</font><br>
<font face="arial,helvetica,georgia,verdana" size="1">Mettler-Toledo AutoChem</font><br>
<font face="arial,helvetica,georgia,verdana" size="1">(410) 910-8100</font><br>
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