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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 K061711
FOIA Releasable 510(k) K061711
Device Name OASIS WOUND MATRIX
Applicant
Cook Biotech, Inc.
1425 Innovation Place
West Lafayette,  IN  47906 -1000
Applicant Contact PERRY W GUINN
Correspondent
Cook Biotech, Inc.
1425 Innovation Place
West Lafayette,  IN  47906 -1000
Correspondent Contact PERRY W GUINN
Classification Product Code
KGN  
Date Received06/19/2006
Decision Date 07/19/2006
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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