FDA 510(k) Application Details - K240703

Device Classification Name Plate, Fixation, Bone

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510(K) Number K240703
Device Name Plate, Fixation, Bone
Applicant BodyCad Laboratories, Inc.
2035 rue du Haut-Bord
Quebec G1N 4R7 CA
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Contact Nadine Adia
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 03/14/2024
Decision Date 04/12/2024
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

FDA Source Information for K240703


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