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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K053022
Device Name SYNTHES (USA) CHRONOS-BETA-TCP
Applicant
Synthes (Usa)
1302 Wrights Ln. E.
West Chester,  PA  19380
Applicant Contact SHERI L MUSGNUNG
Correspondent
Synthes (Usa)
1302 Wrights Ln. E.
West Chester,  PA  19380
Correspondent Contact SHERI L MUSGNUNG
Regulation Number872.3930
Classification Product Code
LYC  
Date Received10/26/2005
Decision Date 01/23/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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