FDA 510(k) Application Details - K071941

Device Classification Name Screw, Fixation, Bone

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510(K) Number K071941
Device Name Screw, Fixation, Bone
Applicant MEMOMETAL TECHNOLOGIES
RUE BLAISE PASCAL
CAMPUS DE KER LANN
BRUZ F35170 FR
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Contact GILLES AUDIC
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 07/13/2007
Decision Date 12/04/2007
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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