BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    FIBER OPTIC LIGHT CABLE

    K Number: K903800 · Decision Aug 29, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    44
    Applicant Total
    2
    Review Days
    9

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    Basic Information

    Device Name
    FIBER OPTIC LIGHT CABLE
    K Number
    K903800
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Orlux Engineering and Instrumentation
    Date Received
    August 20, 1990
    Decision Date
    August 29, 1990
    Product Code
    FST
    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
    FST Light, Surgical, Fiberoptic

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