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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 K230054
Device Name DSM Biomedical Calcium Phosphate Cement
Applicant
Dsm Biomedical
735 Pennsylvania Dr.
Exton,  PA  19431
Applicant Contact Diana Osgood
Correspondent
Dsm Biomedical
735 Pennsylvania Dr.
Exton,  PA  19431
Correspondent Contact Diana Osgood
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
OIS  
Date Received01/06/2023
Decision Date 03/21/2023
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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