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

    FIBER OPTIC LIGHT SOURCE

    K Number: K902784 · Decision Sep 12, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    48
    Applicant Total
    8
    Review Days
    78

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    Basic Information

    Device Name
    FIBER OPTIC LIGHT SOURCE
    K Number
    K902784
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4350
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Trek Medical Products, Inc.
    Date Received
    June 26, 1990
    Decision Date
    September 12, 1990
    Product Code
    EQH
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EQH Source, Carrier, Fiberoptic Light

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