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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K173362
Device Name DSM Biomedical Calcium Phosphate Cement
Applicant
Kensey Nash Corporation Dba Dsm Biomedical
735 Pennsylvania Dr.
Exton,  PA  19431
Applicant Contact Susan Pileggi
Correspondent
Kensey Nash Corporation Dba Dsm Biomedical
735 Pennsylvania Dr.
Exton,  PA  19431
Correspondent Contact Susan Pileggi
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
OIS  
Date Received10/26/2017
Decision Date 04/03/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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