Drills, Burrs, Trephines And Accessories (simple Powered), Reprocessed

Device Code: 3749

Product Code(s): NLN

Device Classification Information

Device Type ID3749
Device NameDrills, Burrs, Trephines And Accessories (simple Powered), Reprocessed
Regulation DescriptionPowered Simple Cranial Drills, Burrs, Trephines, And Their Accessories.
Regulation Medical SpecialtyNeurology
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Neurodiagnostic And Neurosurgical Devices Branch (NDNB)
Submission Type510(k)
CFR Regulation Number882.4310 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNLN
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3749
DeviceDrills, Burrs, Trephines And Accessories (simple Powered), Reprocessed
Product CodeNLN
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionPowered Simple Cranial Drills, Burrs, Trephines, And Their Accessories.
CFR Regulation Number882.4310 [🔎]
TPLC Last Update: 2019-04-02 20:35:57

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.