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510(k) Data Aggregation

    K Number
    K091690
    Device Name
    SHARP CHUTE
    Date Cleared
    2009-07-28

    (48 days)

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

    HEATHROW SCIENTIFIC, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sharp Chute TM is an over-the-counter, single-use, disposable, non-sterile sharps container intended to be used with medical sharps including, but not limited to, hypodermic needles, syringes, lancets, and blood needles. The containers can be used in any area requiring sharps collection prior to their final disposal. When the container is filled to the max-capacity indicator, it is intended to be permanently locked and ultimately disposed of.
    Device Description
    The Sharp Chute ™ is a portable, 1.5 quart sharps container designed to be used in . environments where larger containers are not desired. In addition, it is designed to fit into Heathrow Scientific's Droplet™ Blood Collection Tray. The Sharp Chute ™ is available in either translucent red or translucent yellow. Each component of the container assembly is made of injection molded polypropylene. The end user will be required to attach the dome assembly to the base by inserting the . connection tabs into their corresponding slots. The Sharp Chute "1 is designed to withstand punctures by syringes, pen needles, and . lancets. The Sharp Chute "M is autoclavable and incineratable. . The Sharp Chute TM is NOT reusable. .
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