FDA 510(k) Application Details - K940744

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

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510(K) Number K940744
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant SOFAMOR CO.
158, RUE DE L'EGLISE - B.P.4
62180 RANG DU FLIERS
FRANCE FR
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Contact BRIAN GOODEN
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Regulation Number 888.3060

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Classification Product Code KWQ
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Date Received 02/17/1994
Decision Date 01/30/1996
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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