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: 08/09/2019
Date Received: 03/13/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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: 08/09/2019
Date Received: 03/13/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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