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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
Applicant Contact MARK BLEYER
Correspondent
Cook Biotech, Inc.
3055 Kent Ave.
West Lafayette,  IN  47906
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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