Binder, Elastic

Device Code: 2628

Product Code(s): KMO

Device Classification Information

Device Type ID2628
Device NameBinder, Elastic
Regulation DescriptionTherapeutic Medical Binder.
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 Number880.5160 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKMO
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2628
DeviceBinder, Elastic
Product CodeKMO
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionTherapeutic Medical Binder.
CFR Regulation Number880.5160 [🔎]
TPLC Last Update: 2019-04-02 20:16:24

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