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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 K020732
FOIA Releasable 510(k) K020732
Device Name SS MATRIX
Applicant
Cook Biotech, Inc.
3055 Kent Ave.
West Lafayette,  IN  47906 -1076
Applicant Contact MARK BLEYER
Correspondent
Cook Biotech, Inc.
3055 Kent Ave.
West Lafayette,  IN  47906 -1076
Correspondent Contact MARK BLEYER
Classification Product Code
KGN  
Date Received03/06/2002
Decision Date 05/30/2002
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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