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

    ROCKET INTRAUTERINE SOUND

    K Number: K883806 · Decision Oct 31, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    9
    Applicant Total
    23
    Review Days
    54

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    Basic Information

    Device Name
    ROCKET INTRAUTERINE SOUND
    K Number
    K883806
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    A & A Medical, Inc.
    Date Received
    September 7, 1988
    Decision Date
    October 31, 1988
    Product Code
    HHM
    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
    HHM Sound, Uterine

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