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

    CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR

    K Number: K904366 · Decision Oct 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    61
    Same Product Code
    179
    Applicant Total
    5
    Review Days
    25

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    Basic Information

    Device Name
    CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR
    K Number
    K904366
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Douglas James Donaldson Compliance Services
    Date Received
    September 24, 1990
    Decision Date
    October 19, 1990
    Product Code
    HQF
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQF Laser, Ophthalmic

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