FDA 510(k) Application Details - K132363

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

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510(K) Number K132363
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant CITIEFFE S.R.L.
110 E. GRANADA BLVD
SUITE 209
ORMOND BEACH, FL 32176 US
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Contact Claude Berthoin
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Regulation Number 888.3030

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Classification Product Code KTT
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Date Received 07/30/2013
Decision Date 01/16/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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