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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 K971009
Device Name SCAR CARE
Applicant
Target Health, Inc.
310 Madison Ave., 22nd Floor
New York,  NY  10017
Applicant Contact JULES T MITCHEL
Correspondent
Target Health, Inc.
310 Madison Ave., 22nd Floor
New York,  NY  10017
Correspondent Contact JULES T MITCHEL
Regulation Number878.4025
Classification Product Code
MDA  
Date Received03/20/1997
Decision Date 07/29/1997
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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