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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wound dressing with animal-derived material(s)
510(k) Number K935189
Device Name E-Z DERM BIOSYNTHETIC WOUND DRESSING
Applicant
BRENNEN MEDICAL, INC.
1290 HAMMOND RD.
ST. PAUL,  MN  55110
Applicant Contact JEFFREY M WILLIAMS
Correspondent
BRENNEN MEDICAL, INC.
1290 HAMMOND RD.
ST. PAUL,  MN  55110
Correspondent Contact JEFFREY M WILLIAMS
Classification Product Code
KGN  
Date Received10/26/1993
Decision Date 07/11/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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