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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 K160136
Device Name Flowable Wound Matrix
Applicant
Cook Biotech Incorporated
1425 Innovation Pl.
West Lafayette,  IN  47906
Applicant Contact PERRY W. GUINN
Correspondent
Cook Biotech Incorporated
1425 Innovation Pl.
West Lafayette,  IN  47906
Correspondent Contact NICK WANG
Classification Product Code
KGN  
Date Received01/20/2016
Decision Date 09/28/2016
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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