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510(k) Data Aggregation

    K Number
    K970383
    Device Name
    SHARPS CONTAINER
    Date Cleared
    1997-07-03

    (150 days)

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

    CUSTOM MEDICAL PLASTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Our Horizontal Entry Sharps Containers provide a receptacle for used, contaminated medical Sharps and for enclosure during transport to ultimate disposal.
    Device Description
    Our Horizontal Entry Sharps Container consists of an injectionmolded polypropylene container fitted with a snap-on, leakresistant, poly-propylene lid. The lid has a "mail-box" style raised opening into which the sharps are dropped horizontally. When the container is full, a unique butterfly closure system closes to prevent over-filling and to prevent access to the sharps inside.
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    K Number
    K970398
    Device Name
    SHARPS CONTAINER
    Date Cleared
    1997-07-03

    (150 days)

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

    CUSTOM MEDICAL PLASTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Our Vertical Entry Sharps Containers provide a receptacle for used, contaminated medical Sharps and for enclosure during transport to ultimate disposal.
    Device Description
    Our Vertical Entry Sharps Container consists of an injectionmolded polypropylene container fitted with a tabs down, leakresistant, polypropylene lid. The lid has a chimney-type opening into which the sharps are dropped vertically.
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