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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 K990651
Device Name SKIN 2 FORTE SILICONE SHEETING
Applicant
United Hospital Technologies, Inc.
10320 Usa Today Way
Miramar,  FL  33025
Applicant Contact SAMUEL SWETLAND
Correspondent
United Hospital Technologies, Inc.
10320 Usa Today Way
Miramar,  FL  33025
Correspondent Contact SAMUEL SWETLAND
Regulation Number878.4025
Classification Product Code
MDA  
Date Received03/01/1999
Decision Date 08/13/1999
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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