BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    INFLAT-O-BALL

    K Number: K904026 · Decision Oct 10, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    40
    Applicant Total
    8
    Review Days
    41

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    Basic Information

    Device Name
    INFLAT-O-BALL
    K Number
    K904026
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.3575
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Milex Products, Inc.
    Date Received
    August 30, 1990
    Decision Date
    October 10, 1990
    Product Code
    HHW
    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
    HHW Pessary, Vaginal

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