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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 K993335
Device Name SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM
Applicant
SYNTHES (USA)
1600 RUSSELL RD.
PAOLI,  PA  19301
Applicant Contact SHERI L MUSGNUNG
Correspondent
SYNTHES (USA)
1600 RUSSELL RD.
PAOLI,  PA  19301
Correspondent Contact SHERI L MUSGNUNG
Regulation Number888.4540
Classification Product Code
HTO  
Subsequent Product Code
HRX  
Date Received10/04/1999
Decision Date 06/12/2000
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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