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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, fixation, spinal interlaminal
510(k) Number K121979
Device Name PASS OCT SPINAL SYSTEM
Original Applicant
MEDICREA INTERNATIONAL
14 porte du grand lyon
neyron,  FR 01700
Original Contact laura aviron-violet
Regulation Number888.3050
Classification Product Code
KWP  
Date Received07/06/2012
Decision Date 03/21/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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