FDA 510(k) Application Details - K120740

Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue

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510(K) Number K120740
Device Name Fastener, Fixation, Nondegradable, Soft Tissue
Applicant FOURNITURES HOSPITALIERES INDUSTRIE
ZI DE KERNEVEZ-6 RUE NOBEL
QUIMPER 29000 FR
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Contact PATRICIA DONNARD
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Regulation Number 888.3040

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Classification Product Code MBI
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Date Received 03/12/2012
Decision Date 03/05/2013
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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