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FDA 510(k) Application Details - K170245
Device Classification Name
Bone Grafting Material, Animal Source
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510(K) Number
K170245
Device Name
Bone Grafting Material, Animal Source
Applicant
Kensey Nash Corporation dba DSM Biomedical
735 Pennsylvania Drive
Exton, PA 19341 US
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Contact
Susan Pileggi
Other 510(k) Applications for this Contact
Regulation Number
872.3930
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Classification Product Code
NPM
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More FDA Info for this Product Code
Date Received
01/26/2017
Decision Date
05/16/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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