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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elastomer, Silicone, For Scar Management
510(k) Number K083718
Device Name BEAU RX SCAR CARE GEL
Applicant
Beau RX Solutions, LLC
P.O. Box 51-1117
Melbourne Beach,  FL  32951
Applicant Contact THOMAS L MCGRAW
Correspondent
Beau RX Solutions, LLC
P.O. Box 51-1117
Melbourne Beach,  FL  32951
Correspondent Contact THOMAS L MCGRAW
Regulation Number878.4025
Classification Product Code
MDA  
Date Received12/15/2008
Decision Date 01/26/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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