BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MINNESOTA SCIENTIFIC, INC. OMNI-BEAM

    K Number: K853948 · Decision Oct 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    27
    Applicant Total
    5
    Review Days
    22

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    Basic Information

    Device Name
    MINNESOTA SCIENTIFIC, INC. OMNI-BEAM
    K Number
    K853948
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Minnesota Scientific, Inc.
    Date Received
    September 24, 1985
    Decision Date
    October 16, 1985
    Product Code
    HBI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HBI Illuminator, Fiberoptic, Surgical Field

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