Set, Oral Administration

Device Code: 2523

Product Code(s): LEY

Device Classification Information

Device Type ID2523
Device NameSet, Oral Administration
Regulation DescriptionGastrointestinal Tube And Accessories.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type510(k)
CFR Regulation Number876.5980 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeLEY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2523
DeviceSet, Oral Administration
Product CodeLEY
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionGastrointestinal Tube And Accessories.
CFR Regulation Number876.5980 [🔎]
TPLC Last Update: 2019-04-02 20:13:44

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