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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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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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