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510(k) Data Aggregation

    K Number
    K123807
    Device Name
    SHARPSCAN
    Date Cleared
    2013-07-23

    (224 days)

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

    MEDICAL ENGINEERING DEVELOPMENT SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The sharpsCAN™ Model I Pint required to be used with a wall mount unit accessory is intended for single use and for the disposal of contaminated medical sharps in health care facilities. This device is not intended for areas with unsupervised patient access.
    Device Description
    The SharpsCAN™ is a disposable sharps container that is intended for the safe disposal of used medical sharps. This sharpsCAN™ is marketed as one model. - sharpsCAN™ Model 1 pint, The sharpsCAN™ container is stable, closable, puncture resistant, impact resistant, and leak-proof on both the sides and bottom. The sharpsCAN™ uses a vertical opening for the disposal of sharps and is intended to be used in an upright position during use with the required wall mount unit accessory.
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