BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    WATER WORKS DOUCHING DEVICE

    K Number: K080200 · Decision Jul 10, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    167

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    Basic Information

    Device Name
    WATER WORKS DOUCHING DEVICE
    K Number
    K080200
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.5900
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Research Group, Inc.
    Date Received
    January 25, 2008
    Decision Date
    July 10, 2008
    Product Code
    HED
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HED Douche Apparatus, Vaginal, Therapeutic

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