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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 K955664
Device Name STERILIZED TRI BLOCK POLYMER GEL SHEET
Applicant
Silipos, Inc.
366 Madison Ave.
Suite 1616
New York,  NY  10017
Applicant Contact ROBERT L GOULD
Correspondent
Silipos, Inc.
366 Madison Ave.
Suite 1616
New York,  NY  10017
Correspondent Contact ROBERT L GOULD
Regulation Number878.4025
Classification Product Code
MDA  
Date Received12/13/1995
Decision Date 02/28/1996
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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