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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 K950032
Device Name MEDISKIN(R) SS, ZENODERM BIOLOGICAL WOUND DRESSING
Applicant
Brennen Medical, Inc.
1290 Hammond Rd.
St. Paul,  MN  55110
Applicant Contact THOMAS A DOLD
Correspondent
Brennen Medical, Inc.
1290 Hammond Rd.
St. Paul,  MN  55110
Correspondent Contact THOMAS A DOLD
Classification Product Code
KGN  
Date Received01/04/1995
Decision Date 06/28/1995
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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