FDA 510(k) Application Details - K132574

Device Classification Name

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510(K) Number K132574
Device Name PASS LP SPINAL SYSTEM
Applicant MEDICREA INTERNATIONAL
14 PORTE DU GRAND LYON
NEYRON 01700 FR
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Contact AUDREY VION
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Regulation Number

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Classification Product Code OSH
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Date Received 08/16/2013
Decision Date 11/08/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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