FDA 510(k), K192162, NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate

FDA 510(k), K192162, NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate

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510(K) Number: K192162
Device Name: NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
Manufacturer: Rohit Khanna
Device Classification Name: Cover, Burr Hole
Regulation Number: GXR
Classification Product Code: KXA
Date Received: 08/09/2019
Decision Date: 03/13/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology

459 pages (1,048 of 1,507 original pages are fully redacted)

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