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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 K053228
Device Name THERIGRAFT TCP PUTTY BONE VOID FILLER
Applicant
Therics, LLC
115 Campus Dr.
Princeton,  NJ  08540
Applicant Contact SUNIL SAINI
Correspondent
Therics, LLC
115 Campus Dr.
Princeton,  NJ  08540
Correspondent Contact SUNIL SAINI
Regulation Number888.3045
Classification Product Code
MQV  
Date Received11/18/2005
Decision Date 01/31/2006
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
Recalls CDRH Recalls
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