FDA 510(k) Application Details - K131005

Device Classification Name Rod, Fixation, Intramedullary And Accessories

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510(K) Number K131005
Device Name Rod, Fixation, Intramedullary And Accessories
Applicant CITIEFFE S.R.L.
110 E. GRANADA BLVD
SUITE 209
ORMOND BEACH, FL 32176 US
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Contact CLAUDE BERTHION
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Regulation Number 888.3020

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Classification Product Code HSB
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Date Received 04/11/2013
Decision Date 06/25/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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