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510(k) Data Aggregation

    K Number
    K973293
    Device Name
    SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR
    Manufacturer
    VAUGHAN WEEKS
    Date Cleared
    1997-11-18

    (77 days)

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

    VAUGHAN WEEKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Syntec, Inc. True Light End Irrigating Endoilluminator is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and to provide irrigation during vitreo-retinal surgery.
    Device Description
    The End Irrigating Endoilluminator comprises of five basic components. The handpiece tube. The fiberoptic handle. The fiber optic cable sheath and the cable connector.
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    K Number
    K973290
    Device Name
    SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK
    Manufacturer
    VAUGHAN WEEKS
    Date Cleared
    1997-11-14

    (73 days)

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

    VAUGHAN WEEKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Syntec, Inc. True Light Endoilluminator with Pick is used to illuminate with visible spectrum light the intra ocular portion of the eye for improved visualization and manipulation during vitreo-retinal surgery.
    Device Description
    The Endoilluminator with Pick 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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