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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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