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510(k) Data Aggregation

    K Number
    K063722
    Device Name
    SEKURIT SHARPS COLLECTION CONTAINER
    Date Cleared
    2007-03-05

    (80 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHEN SAFETY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Techen Safety Sharps Disposal Containers with Screw Top Caps are intended for single use disposal of used or contaminated medical sharps, including but not limited to, hypodermic needles, syringes, lancets, and Blood Needles. The containers can be used in a variety of healthcare settings. They are suitable for physicians offices, dental offices, laboratories, home health, patient room, and other generation of medical waste.
    Device Description
    The Sekurit Sharps Collection Container is a single piece container which is blow molded of High Density Polyethylene plastic and is available in 1 Gallon, 3 Gallon, 3 Gallon and 1.4 quart sizes. Each container is of the same design type and altered only in its height to achieve the needed capacities. The containers are available in translucent red and yellow colors as well as . opaque red and yellow colors. Sekurit Sharps Collection Containers have a threaded screw neck and utilize a puncture resistant screw cap molded from Polypropylene. These containers are NOT reusable.
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