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510(k) Data Aggregation

    K Number
    K980003
    Device Name
    M500-100 SHARPS CONTAINER
    Date Cleared
    1998-03-13

    (70 days)

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

    IMAGINATION MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The M500-100 sharps container is designed to hold up to 30 syringes from 1 to 5 cc in size. This container is intended for use by trained medical personnel in a medical clinic setting for the safe disposal of hazardous sharps.
    Device Description
    The M500-100 Sharps Container was compared to the below mentioned predicate containers in that it conforms to the same standards as its predicates. This container was made from polyethylene plastic with a polyethylene locking lid. This container was molded with no side or bottom seams. The predicate devices are also made of premotited polyethylene. The M500-100 has a lid, which locks when shut preventing any leakage or loss of its contents. The M500-100 is designed to hold up to 30 used syringes of lec to 5cc in size. The syringes are placed into the container in a vertical position sharp side down. Other sharps may be disposed of by dropping them into the opening at the top. The M500-100 sharps container has a flat bottom, which makes it stable when sitting on a table. This container can also be placed in a specially designed wall bracket. There is a black line on this container to notify the user not to overfill .
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