FDA 510(k) Application Details - K234036

Device Classification Name Manipulator, Plunger-Like Joint

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510(K) Number K234036
Device Name Manipulator, Plunger-Like Joint
Applicant Neuro Spinal Innovation Inc
77 City Centre Drive, Suite 501, East Tower
Mississauga L5B 1M5 CA
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Contact Aslam Khan
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Regulation Number 000.0000

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Classification Product Code LXM
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Date Received 12/21/2023
Decision Date 02/15/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K234036


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