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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bone grafting material, animal source
510(k) Number K170245
Device Name DSM Biomedical Dental Bone Graft
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 Number872.3930
Classification Product Code
NPM  
Date Received01/26/2017
Decision Date 05/16/2017
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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