FDA 510(k) Application Details - K932330

Device Classification Name Rod, Fixation, Intramedullary And Accessories

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510(K) Number K932330
Device Name Rod, Fixation, Intramedullary And Accessories
Applicant SYNTHES (USA)
1690 RUSSELL RD.
POST OFFICE BOX 1766
PAOLI, PA 19301 US
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Contact DIANE COCHET-WYNANT
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Regulation Number 888.3020

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Classification Product Code HSB
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Date Received 05/13/1993
Decision Date 03/08/1996
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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