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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze / Sponge,Nonresorbable For External Use
510(k) Number K914604
Device Name MEPITEL NON-ADHERENT SILICONE DRESSING
Applicant
Molnlycke Clinical Products AB
C/O Swedish Trade Council
150 N. Michigan Ave., Suite 1200
Chicago,  IL  60601
Applicant Contact SVEN E SIEVERS
Correspondent
Molnlycke Clinical Products AB
C/O Swedish Trade Council
150 N. Michigan Ave., Suite 1200
Chicago,  IL  60601
Correspondent Contact SVEN E SIEVERS
Regulation Number878.4014
Classification Product Code
NAB  
Date Received10/17/1991
Decision Date 03/25/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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