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

    SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE

    K Number: K910980 · Decision May 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    55
    Same Product Code
    107
    Applicant Total
    30
    Review Days
    76

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    Basic Information

    Device Name
    SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE
    K Number
    K910980
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Site Microsurgical Systems, Inc.
    Date Received
    March 7, 1991
    Decision Date
    May 22, 1991
    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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