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FDA 510(k) Application Details - K112197
Device Classification Name
Pin, Fixation, Smooth
More FDA Info for this Device
510(K) Number
K112197
Device Name
Pin, Fixation, Smooth
Applicant
MEMOMETAL TECHNOLOGIES
CAMPUS DE KER LANN
RUE BLAISE PASCAL
BRUZ F35170 FR
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Contact
GILLES AUDIC
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HTY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/01/2011
Decision Date
11/17/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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