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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Source, Fiberoptic, Routine
510(k) Number K093792
Device Name LED LIGHT SOURCE
Applicant
Sunoptic Technologies, LLC
6018 Bowdendale Ave.
Jacksonville,  FL  32216
Applicant Contact JANICE G LEE
Correspondent
Sunoptic Technologies, LLC
6018 Bowdendale Ave.
Jacksonville,  FL  32216
Correspondent Contact JANICE G LEE
Regulation Number876.1500
Classification Product Code
FCW  
Date Received12/10/2009
Decision Date 03/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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