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

    DRUSHOE

    K Number: K790326 · Decision Feb 26, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    203
    Registration Numbers
    203
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    11

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    Basic Information

    Device Name
    DRUSHOE
    K Number
    K790326
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3475
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    J.E. Hanger & Co. , Ltd.
    Date Received
    February 15, 1979
    Decision Date
    February 26, 1979
    Product Code
    KNP
    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
    KNP Orthosis, Corrective Shoe

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