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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reamer
510(k) Number K042899
FOIA Releasable 510(k) K042899
Device Name SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS
Applicant
Synthes (Usa)
1690 Russell Rd.
Paoli,  PA  19301
Applicant Contact SHERI L MUSGNUNG
Correspondent
Synthes (Usa)
1690 Russell Rd.
Paoli,  PA  19301
Correspondent Contact SHERI L MUSGNUNG
Regulation Number888.4540
Classification Product Code
HTO  
Subsequent Product Code
NBH  
Date Received10/20/2004
Decision Date 03/16/2005
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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