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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 K081635
Device Name INTEGRA MESHED BILAYER WOUND MATRIX
Applicant
INTEGRA LIFESCIENCES CORP.
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Applicant Contact DIANA M BORDON
Correspondent
INTEGRA LIFESCIENCES CORP.
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Correspondent Contact DIANA M BORDON
Classification Product Code
KGN  
Date Received06/11/2008
Decision Date 12/04/2008
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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