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

    CAST SHOE

    K Number: K781363 · Decision Aug 14, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    93
    Registration Numbers
    93
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    7

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    Basic Information

    Device Name
    CAST SHOE
    K Number
    K781363
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3025
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Cutler Biomedical
    Date Received
    August 7, 1978
    Decision Date
    August 14, 1978
    Product Code
    IPG
    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
    IPG Shoe, Cast

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