FDA 510(k) Application Details - K142502

Device Classification Name Plate, Fixation, Bone

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510(K) Number K142502
Device Name Plate, Fixation, Bone
Applicant NEWCLIP TECHNICS
PA de la Lande Saint Martin û 45 rue des GarottiΦres
HAUTE-GOULAINE 44115 FR
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Contact Gaδlle LUSSORI
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 09/05/2014
Decision Date 12/23/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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