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510(k) Data Aggregation

    K Number
    K161255
    Device Name
    meso-relle (AAL34, AAL36, AM30G)
    Manufacturer
    Date Cleared
    2017-01-19

    (261 days)

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

    BIOTEKNE SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The meso-relle needles are intended to inject fluids intradermally.
    Device Description
    The meso-relle® needles are single lumen needle intended to inject fluids intradermally. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe. Needles have different length, which make them suitable to inject fluids intradermally. The meso-relle are not intended for injection in the bloodstream. The devices do not contact the central nervous system. The meso-relle® needles are suitable for administration of fluids intradermally. Each needle is provided with a protective cap (cover is rigid and not colored. The dimensions are suitable to accommodate the corresponding needle and vary according to the dimensions of the needle. The meso-relle® needles are disposable single use devices, sold sterilized by ethylene oxide.
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