FDA 510(k) Application Details - K172485

Device Classification Name Pin, Fixation, Smooth

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510(K) Number K172485
Device Name Pin, Fixation, Smooth
Applicant Newclip Technics
PA de la Lande Saint Martin - 45 rue des Garottieres
Haute-Goulaine 44 115 FR
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Contact Gaelle Lussori
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Regulation Number 888.3040

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Classification Product Code HTY
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Date Received 08/17/2017
Decision Date 03/02/2018
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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