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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cerclage, fixation
510(k) Number K050041
Device Name SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Applicant Contact LISA M BOYLE
Correspondent
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Correspondent Contact LISA M BOYLE
Regulation Number888.3010
Classification Product Code
JDQ  
Subsequent Product Codes
HRS   HWC  
Date Received01/07/2005
Decision Date 02/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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