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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 K132025
Device Name MESO BILAYER SURGICAL MESH
Applicant
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL
735 PENNSYLVANIA DRIVE
EXTON,  PA  19341
Applicant Contact Susan Pileggi
Correspondent
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL
735 PENNSYLVANIA DRIVE
EXTON,  PA  19341
Correspondent Contact Susan Pileggi
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
OXH  
Date Received07/01/2013
Decision Date 10/30/2013
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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