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

    ROCKER-SOLE CAST SANDAL

    K Number: K760575 · Decision Oct 6, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    93
    Registration Numbers
    93
    Same Product Code
    5
    Applicant Total
    48
    Review Days
    33

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    Basic Information

    Device Name
    ROCKER-SOLE CAST SANDAL
    K Number
    K760575
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3025
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Richard'S Medical Equip., Inc.
    Date Received
    September 3, 1976
    Decision Date
    October 6, 1976
    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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