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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
Original Applicant
KENSEY NASH CORPORATION
735 pennsylvania drive
exton,  PA  19341
Original Contact lori a burns, ms, rac
Regulation Number878.3300
Classification Product Code
FTM  
Date Received12/31/2009
Decision Date 05/18/2010
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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