FDA 510(k) Application Details - K241539

Device Classification Name Plate, Fixation, Bone

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510(K) Number K241539
Device Name Plate, Fixation, Bone
Applicant Newclip Technics
PA de la Lande Saint Martin
45 rue des GarottiΦres
Haute-Goulaine 44115 FR
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Contact Gaδlle Gourbiere
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 05/31/2024
Decision Date 07/30/2024
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

FDA Source Information for K241539


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