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

    DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID

    K Number: K800954 · Decision Oct 3, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    11
    Applicant Total
    29
    Review Days
    163

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    Basic Information

    Device Name
    DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID
    K Number
    K800954
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.5900
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    The Healthcare Group Laboratories, Inc.
    Date Received
    April 23, 1980
    Decision Date
    October 3, 1980
    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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