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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K053655
Device Name TENDON WRAP TENDON PROTECTOR
Applicant
INTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Applicant Contact DIANA M BORDON
Correspondent
INTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Correspondent Contact DIANA M BORDON
Regulation Number878.3300
Classification Product Code
FTM  
Date Received12/30/2005
Decision Date 02/03/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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