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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
Recalls CDRH Recalls
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