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510(k) Data Aggregation

    K Number
    K230070
    Device Name
    MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM®
    Manufacturer
    PromaMedical Inc.
    Date Cleared
    2023-10-05

    (268 days)

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

    PromaMedical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MESORAM® Hypodermic Needles are intended to inject fluids intradermally.
    Device Description
    MESORAM hypodermic needles are single lumen hypodermic needles that will inject fluids into the intradermal space. The device consists of an AISI 304 stainless steel tube that is sharpened at one end, with the other end joined to a female connector (luer) designed to mate with a male connector. MESORAM hypodermic needles are available in gauges 27 G, 30 G, 32 G, and 33 G, with varying needle lengths and outer diameters. The needles feature a protective tip cover which is formed of rigid polypropylene.
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