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

    S1500 XENON LIGHT SOURCE

    K Number: K922837 · Decision Nov 3, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    27
    Applicant Total
    7
    Review Days
    144

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    Basic Information

    Device Name
    S1500 XENON LIGHT SOURCE
    K Number
    K922837
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Endomedix
    Date Received
    June 12, 1992
    Decision Date
    November 3, 1992
    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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