Cover, Cast

Device Code: 2620

Product Code(s): KIA

Device Classification Information

Device Type ID2620
Device NameCover, Cast
Regulation DescriptionCast Cover.
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 Number880.6185 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKIA
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2620
DeviceCover, Cast
Product CodeKIA
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionCast Cover.
CFR Regulation Number880.6185 [🔎]
TPLC Last Update: 2019-04-02 20:16:16

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