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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 K974143
Device Name KMC NEWSKIN
Applicant
Kmc Intl. Co.
1260 Lincoln Ave., #1200
Pasadena,  CA  91103
Applicant Contact CINDIE SHIMM
Correspondent
Kmc Intl. Co.
1260 Lincoln Ave., #1200
Pasadena,  CA  91103
Correspondent Contact CINDIE SHIMM
Regulation Number878.4025
Classification Product Code
MDA  
Date Received11/03/1997
Decision Date 03/27/1998
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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