Support, Scrotal, Therapeutic

Device Code: 2589

Product Code(s): FQJ

Device Classification Information

Device Type ID2589
Device NameSupport, Scrotal, Therapeutic
Regulation DescriptionTherapeutic Scrotal Support.
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 Number880.5820 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFQJ
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2589
DeviceSupport, Scrotal, Therapeutic
Product CodeFQJ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionTherapeutic Scrotal Support.
CFR Regulation Number880.5820 [🔎]
TPLC Last Update: 2019-04-02 20:15:37

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