FDA 510(k) Application Details - K141187

Device Classification Name

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510(K) Number K141187
Device Name IMPIX ALIF S/A
Applicant MEDICREA INTERNATIONAL S.A.
14 PORTE DU GRAND LYON
NEYRON 01700 FR
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Contact DAVID RYAN
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Regulation Number

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Classification Product Code OVD
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Date Received 05/08/2014
Decision Date 01/15/2015
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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