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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 K932048
Device Name SILICONE GEL SHEETING
Applicant
Silipos, Inc.
366 Madison Ave.
Suite 1616
New York,  NY  10017
Applicant Contact ROBERT GOULD
Correspondent
Silipos, Inc.
366 Madison Ave.
Suite 1616
New York,  NY  10017
Correspondent Contact ROBERT GOULD
Regulation Number878.4025
Classification Product Code
MDA  
Date Received04/27/1993
Decision Date 01/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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