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FDA 510(k) Application Details - K940744
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
888.3060
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Classification Product Code
KWQ
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More FDA Info for this Product Code
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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