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

    PRENATAL WEDGE

    K Number: K895343 · Decision Sep 29, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    65
    Applicant Total
    1
    Review Days
    28

    Basic Information

    Device Name
    PRENATAL WEDGE
    K Number
    K895343
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5880
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    KAY ENT.
    Date Received
    September 1, 1989
    Decision Date
    September 29, 1989
    Product Code
    JFB
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JFB Table, Physical Therapy, Multi Function

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