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510(k) Data Aggregation

    K Number
    K964555
    Device Name
    VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)
    Manufacturer
    VITROTEC, INC.
    Date Cleared
    1997-03-31

    (138 days)

    Product Code
    MPA
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITROTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Syntec, Inc. Disposable Endo Illuminators is used to illuminate with visible spectrum light the intraocuiar portion of the eye for improved visualization during vitreo-retinal surgery.
    Device Description
    The Endo Illuminator is comprised of five basic components. The handpiece handle. The handpiece tube. The fiberoptic cable. The fiber optic cable sheath and the connector.
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