Device, Vein Stabilization

Device Code: 2647

Product Code(s): LBJ

Device Classification Information

Device Type ID2647
Device NameDevice, Vein Stabilization
Regulation DescriptionVein Stabilizer.
Regulation Medical SpecialtyGeneral Hospital
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) Exempt
CFR Regulation Number880.6980 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeLBJ
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2647
DeviceDevice, Vein Stabilization
Product CodeLBJ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionVein Stabilizer.
CFR Regulation Number880.6980 [🔎]
TPLC Last Update: 2019-04-02 20:16:41

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