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FDA 510(k) Application Details - K234036
Device Classification Name
Manipulator, Plunger-Like Joint
More FDA Info for this Device
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
More FDA Info for this Regulation Number
Classification Product Code
LXM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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