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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K953334
Device Name SYNTHES FLEXNAIL
Applicant
Synthes (Usa)
1690 Russell Rd.
P.O. Box 1766
Paoli,  PA  19301
Applicant Contact ANGELA J SILVESTRI
Correspondent
Synthes (Usa)
1690 Russell Rd.
P.O. Box 1766
Paoli,  PA  19301
Correspondent Contact ANGELA J SILVESTRI
Regulation Number888.3020
Classification Product Code
HSB  
Date Received07/17/1995
Decision Date 10/31/1995
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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