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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 K094061
Device Name KENSEY NASH ECM SURGICAL PATCH
Applicant
KENSEY NASH CORPORATION
735 PENNSYLVANIA DRIVE
EXTON,  PA  19341
Applicant Contact LORI A BURNS, MS, RAC
Correspondent
KENSEY NASH CORPORATION
735 PENNSYLVANIA DRIVE
EXTON,  PA  19341
Correspondent Contact LORI A BURNS, MS, RAC
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
OXE   OXH   PAG   PAJ  
Date Received12/31/2009
Decision Date 05/18/2010
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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