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510(k) Data Aggregation

    K Number
    K963830
    Device Name
    SHARPS CONTAINER MODEL# SC001
    Manufacturer
    IMAGE MEDICAL, INC.
    Date Cleared
    1997-02-10

    (139 days)

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

    IMAGE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This container is for use by Law Enforcement Agencies. Law Enforcement Officials who frequently ancounter syringes and other sharps during searches of suspects, vahicles, property or location.
    Device Description
    A ans piece aluminum container designed for the wate and examinated needles and syringes. Container is designed of thin walled puncture resistant 6081 aluminum with a screw on leak proof lld. Container is designed to held up to two (2) 1cc syringes and is completely disposable in accordance with local and state regulations.
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