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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 K993948
Device Name SIS WOUND DRESSING II
Applicant
Cook Biotech, Inc.
3055 Kent Ave.
West Lafayette,  IN  47906
Applicant Contact NEAL E FEARNOT
Correspondent
Cook Biotech, Inc.
3055 Kent Ave.
West Lafayette,  IN  47906
Correspondent Contact NEAL E FEARNOT
Classification Product Code
KGN  
Date Received11/22/1999
Decision Date 01/06/2000
Decision Substantially Equivalent (SESE)
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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