Bistoury, Tracheal

Device Code: 1566

Product Code(s): KCC

Device Classification Information

Device Type ID1566
Device NameBistoury, Tracheal
Regulation DescriptionEar, Nose, And Throat Manual Surgical Instrument.
Regulation Medical SpecialtyEar Nose & Throat
Review PanelEar Nose & Throat
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Ear, Nose, And Throat Devices Branch (ENTB)
Submission Type510(K) Exempt
CFR Regulation Number874.4420 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKCC
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1566
DeviceBistoury, Tracheal
Product CodeKCC
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEar, Nose, And Throat Manual Surgical Instrument.
CFR Regulation Number874.4420 [🔎]
TPLC Last Update: 2019-04-02 19:55:56

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