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

    MASTERHINGE

    K Number: K833084 · Decision Oct 14, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    30
    Applicant Total
    5
    Review Days
    31

    Basic Information

    Device Name
    MASTERHINGE
    K Number
    K833084
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.5940
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    MARK ONE HEALTHCARE PRODUCTS
    Date Received
    September 13, 1983
    Decision Date
    October 14, 1983
    Product Code
    LGF
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LGF Component, Cast

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