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FDA 510(k) Application Details - K152966
Device Classification Name
More FDA Info for this Device
510(K) Number
K152966
Device Name
Aequalis Fx2
Applicant
Tornier SAS
161 RUE LAVOISIER
MONTBONNOT SAINT MARTIN 38330 FR
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Contact
JOVILA DODI
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Regulation Number
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Classification Product Code
PHX
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Date Received
10/07/2015
Decision Date
01/14/2016
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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