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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Threaded
510(k) Number K970097
Device Name PROXIMAL FEMORAL NAIL (PFN) SYSTEM
Applicant
Synthes (Usa)
1690 Russell Rd.
Post Office Box 1766
Paoli,  PA  19301
Applicant Contact SHERI L MUSGNUNG
Correspondent
Synthes (Usa)
1690 Russell Rd.
Post Office Box 1766
Paoli,  PA  19301
Correspondent Contact SHERI L MUSGNUNG
Regulation Number888.3040
Classification Product Code
JDW  
Subsequent Product Code
JDS  
Date Received01/13/1997
Decision Date 03/13/1997
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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