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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 K971916
Device Name MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL
Applicant
Medical Z, S.A.
1900 K St. NW
Washington,  DC  20006 -1108
Applicant Contact EMALEE G MURPHY
Correspondent
Medical Z, S.A.
1900 K St. NW
Washington,  DC  20006 -1108
Correspondent Contact EMALEE G MURPHY
Regulation Number878.4025
Classification Product Code
MDA  
Date Received05/23/1997
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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