FDA 510(k) Application Details - K063551

Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

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510(K) Number K063551
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant TORNIER
161 RUE LAVOISIER
MONTBONNOT
SAINT-ISMIER CEDEX 38334 FR
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Contact Mireille Lemery
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Regulation Number 888.3030

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Classification Product Code KTT
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Date Received 11/24/2006
Decision Date 12/22/2006
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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