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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
Applicant
KENSEY NASH CORPORATION
735 PENNSYLVANIA DRIVE
EXTON,  PA  19341
Applicant Contact LORI BURNS, MS, RAC
Correspondent
KENSEY NASH CORPORATION
735 PENNSYLVANIA DRIVE
EXTON,  PA  19341
Correspondent Contact LORI BURNS, MS, RAC
Regulation Number872.3930
Classification Product Code
NPL  
Date Received05/01/2012
Decision Date 07/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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