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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dressing, wound, collagen
510(k) Number K112888
Device Name MESO WOUND MATRIX
Original Applicant
KENSEY NASH CORPORATION
735 pennsylvania drive
exton,  PA  19341
Original Contact lori a burns
Classification Product Code
KGN  
Date Received09/30/2011
Decision Date 02/10/2012
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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