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510(k) Data Aggregation

    K Number
    K073206
    Device Name
    NEEDLE-TRAP/NEEDLE SAFETY LABEL
    Manufacturer
    SCHREINER MEDIPHARM
    Date Cleared
    2008-01-16

    (64 days)

    Product Code
    MEG80M
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHREINER MEDIPHARM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Needle-Trap™ contains a mechanism that is used to cover the needle point after use of the syringe and needle for their intended functions. In the activated position the Needle-Trap™ guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
    Device Description
    The Needle-Trap™ Needle Safety devices are substantially equivalent to the current marketed products
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