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510(k) Data Aggregation

    K Number
    K033950
    Device Name
    DORC VITRECTOMY LENSES, MODEL 1284 SERIES
    Manufacturer
    DUTCH OPHTHALMIC RESEARCH CENTER (D.O.R.C.)
    Date Cleared
    2004-02-20

    (60 days)

    Product Code
    HJK
    Regulation Number
    886.1385
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUTCH OPHTHALMIC RESEARCH CENTER (D.O.R.C.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vitrectomy Lenses are intended to be used in conjunction with an operating microscope as a surgical optic to improve visualization of the ocular fundus, vitreous and retinal structures. Vitrectomy lenses are indicated for use during vitreoretinal surgical procedures.
    Device Description
    D.O.R.C. Vitrectomy Lens includes a variety of designs both sterile, single use, disposable vitrectomy lenses, as well as vitrectomy lenses intended to be reused which are sold non-sterile.
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