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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 K013072
Device Name CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)
Applicant
Synthes
1690 Russell Rd.
Paoli,  PA  19301
Applicant Contact THOMAS M MARGUIRE
Correspondent
Synthes
1690 Russell Rd.
Paoli,  PA  19301
Correspondent Contact THOMAS M MARGUIRE
Regulation Number888.3045
Classification Product Code
MQV  
Date Received09/13/2001
Decision Date 11/26/2002
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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