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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, Collagen, Orthopaedics, Reinforcement Of Tendon
510(k) Number K133169
Device Name MESO TENDON MATRIX
Applicant
Kensey Nash Corporation Dba Dsm Biomedical
735 Pennsylvania Dr.
Exton,  PA  19341
Applicant Contact BRIANNA JORDAN
Correspondent
Kensey Nash Corporation Dba Dsm Biomedical
735 Pennsylvania Dr.
Exton,  PA  19341
Correspondent Contact BRIANNA JORDAN
Regulation Number878.3300
Classification Product Code
OWY  
Date Received10/17/2013
Decision Date 12/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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