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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 K023678
Device Name DIMISIL SCAR GEL
Applicant
Aesthetic and Reconstructive Technologies, Inc.
5871 Lone Pine Pl.
Paso Robles,  CA  93446
Applicant Contact CATHERINE RIPLE
Correspondent
Aesthetic and Reconstructive Technologies, Inc.
5871 Lone Pine Pl.
Paso Robles,  CA  93446
Correspondent Contact CATHERINE RIPLE
Regulation Number878.4025
Classification Product Code
MDA  
Date Received11/01/2002
Decision Date 01/23/2003
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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