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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name barrier, animal source, intraoral
510(k) Number K121310
Device Name MESOTHELIUM DENTAL MEMBRANE
Original Applicant
KENSEY NASH CORPORATION
735 pennsylvania drive
exton,  PA  19341
Original Contact lori burns, ms, rac
Regulation Number872.3930
Classification Product Code
NPL  
Date Received05/01/2012
Decision Date 07/11/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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