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

    SORBOTHANE

    K Number: K810228 · Decision Feb 10, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    203
    Registration Numbers
    203
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    14

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    Basic Information

    Device Name
    SORBOTHANE
    K Number
    K810228
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3475
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Hamilton Kent
    Date Received
    January 27, 1981
    Decision Date
    February 10, 1981
    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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