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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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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