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510(k) Data Aggregation

    K Number
    K080200
    Device Name
    WATER WORKS DOUCHING DEVICE
    Manufacturer
    ABBOTT RESEARCH GROUP, INC.
    Date Cleared
    2008-07-10

    (167 days)

    Product Code
    HED
    Regulation Number
    884.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBOTT RESEARCH GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The WaterWorks® Douching Device is indicated for the reduction or abatement of perceived vaginal odor with or without complaints of discharge in women with no infectious cause of vaginitis.
    Device Description
    The Water Works® Douching Device is a reusable system consisting of a customized 32 ounce, water container, connecting hose and a stainless steel nozzle. A hose clamp for controlling water flow through the hose and a plastic loop to attach the container to a shower head are also provided. The container is filled with tepid tap water which flows through the hose to the nozzle. The water container is hung approximately 3 feet above the vagina (eye-level).
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