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510(k) Data Aggregation

    K Number
    K133425
    Device Name
    SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
    Manufacturer
    ENGINEERED MEDICAL SOLUTIONS CO. LLC.
    Date Cleared
    2013-12-05

    (27 days)

    Product Code
    FTD, FDT
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENGINEERED MEDICAL SOLUTIONS CO. LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scintillant Surgical Lights are intended to provide localized illumination of surgical sites.
    Device Description
    The Scintillant Dual Tip Light is a sterile, single-use device designed to provide surgeons with localized brilliant white illumination of the surgical site. Utilizing an internal battery, the device is designed to stay operational for up to three hours of continuous use. Dual light tips in combination with flexible leads containing memory wire allows for the surgeon to direct light from multiple locations optimizing the illumination provided by the device and allowing for increased visibility within the surgical site.
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