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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
Applicant
MEDICREA INTERNATIONAL
14 porte du grand lyon
neyron, 
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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