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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 K160474
Device Name DSM Biomedical Porcine Pericardium Dental Membrane
Applicant
Kensey Nash Corporation dba DSM Biomedical
735 Pennsylvania Drive
Exton,  PA  19431
Applicant Contact Brianna Schehr
Correspondent
Kensey Nash Corporation dba DSM Biomedical
735 Pennsylvania Drive
Exton,  PA  19431
Correspondent Contact Brianna Schehr
Regulation Number872.3930
Classification Product Code
NPL  
Date Received02/19/2016
Decision Date 06/07/2016
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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