Cannulae, Bronchial

Device Code: 5701

Product Code(s): KCE

Device Classification Information

Device Type ID5701
Device NameCannulae, Bronchial
Regulation DescriptionManual Surgical Instrument For General Use.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1)
Submission Type510(K) Exempt
CFR Regulation Number878.4800 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKCE
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5701
DeviceCannulae, Bronchial
Product CodeKCE
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Surgical Instrument For General Use.
CFR Regulation Number878.4800 [🔎]
TPLC Last Update: 2019-04-02 21:11:03

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