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

    GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72

    K Number: K080776 · Decision Sep 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    55
    Same Product Code
    107
    Applicant Total
    2
    Review Days
    174

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    Basic Information

    Device Name
    GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72
    K Number
    K080776
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Us Ophthalmic, LLC
    Date Received
    March 19, 2008
    Decision Date
    September 9, 2008
    Product Code
    HJO
    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
    HJO Biomicroscope, Slit-Lamp, Ac-Powered

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