Douche Apparatus, Vaginal, Therapeutic

Device Code: 3903

Product Code(s): HED

Device Classification Information

Device Type ID3903
Device NameDouche Apparatus, Vaginal, Therapeutic
Regulation DescriptionTherapeutic Vaginal Douche Apparatus.
Regulation Medical SpecialtyObstetrics/Gynecology
Review PanelObstetrics/Gynecology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Obstetrics And Gynecology Devices Branch (OGDB)
Submission Type510(K) Exempt
CFR Regulation Number884.5900 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHED
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3903
DeviceDouche Apparatus, Vaginal, Therapeutic
Product CodeHED
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionTherapeutic Vaginal Douche Apparatus.
CFR Regulation Number884.5900 [🔎]
TPLC Last Update: 2019-04-02 20:39:48

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