Instrument, Dowel Cutting

Device Code: 3692

Product Code(s): GZQ

Device Classification Information

Device Type ID3692
Device NameInstrument, Dowel Cutting
Regulation DescriptionDowel Cutting Instrument.
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 Number882.4275 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGZQ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID3692
DeviceInstrument, Dowel Cutting
Product CodeGZQ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionDowel Cutting Instrument.
CFR Regulation Number882.4275 [🔎]
TPLC Last Update: 2019-04-02 20:34:35

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