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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Fixation Device, Spinal
510(k) Number K954856
Device Name CANNULATED FEMORAL NAIL
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Applicant Contact ANGELA J SILVESTRI
Correspondent
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Correspondent Contact ANGELA J SILVESTRI
Regulation Number888.3060
Classification Product Code
JDN  
Subsequent Product Code
HTY  
Date Received10/23/1995
Decision Date 03/08/1996
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
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