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    K Number
    K110766
    Device Name
    KOLPLUX SYSTEM
    Manufacturer
    KOLPLAST CI LTDA
    Date Cleared
    2011-09-15

    (181 days)

    Product Code
    HIB, DEV
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOLPLAST CI LTDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KOLPLUX System when used with a vaginal speculum provides illumination during pelvic examination and other gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery.
    Device Description
    The KOLPLUX System consists of a power source adapter, 2 meter long electrical cord, and the illumination system body and a carrying case. The Illumination System Body accommodates the LED and provides a keyhole female opening for the insertion of the optic fiber tube (found on the vaginal speculum).
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