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

    GARDOSI BIRTHING CUSHION

    K Number: K903973 · Decision Sep 27, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    25
    Applicant Total
    55
    Review Days
    30

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    Basic Information

    Device Name
    GARDOSI BIRTHING CUSHION
    K Number
    K903973
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4900
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Graphic Controls Corp.
    Date Received
    August 28, 1990
    Decision Date
    September 27, 1990
    Product Code
    KNC
    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
    KNC Table, Obstetric (And Accessories)

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