FDA 510(k) Application Details - K964259

Device Classification Name Device, Fixation, Proximal Femoral, Implant

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510(K) Number K964259
Device Name Device, Fixation, Proximal Femoral, Implant
Applicant SYNTHES (USA)
1690 RUSSELL RD.
PAOLI, PA 19301 US
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Contact SHERI MUSGNUNG
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Regulation Number 888.3030

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Classification Product Code JDO
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Date Received 10/25/1996
Decision Date 01/09/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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