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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 K021792
FOIA Releasable 510(k) K021792
Device Name BILAYER MATRIX WOUND DRESSING
Applicant
Integra Lifesciences Corp.
311 Enterprise Dr.
Planisboro,  NJ  08536
Applicant Contact DIANA M BORDON
Correspondent
Integra Lifesciences Corp.
311 Enterprise Dr.
Planisboro,  NJ  08536
Correspondent Contact DIANA M BORDON
Classification Product Code
KGN  
Date Received05/31/2002
Decision Date 08/14/2002
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
Recalls CDRH Recalls
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