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510(k) Data Aggregation

    K Number
    K092746
    Device Name
    MICRONJET 600
    Date Cleared
    2010-02-03

    (148 days)

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

    NANOPASS TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MicronJet 600 is intended to be used for injecting fluids into parts of the body below the surface of the skin. The MicronJet 600 is indicated for use in intradermal injections of any substance or drug approved for intradermal delivery.
    Device Description
    The MicronJet 600 Needle is a small plastic adapter (female luer) equipped with a chip having three microneedles designed to mate with any standard syringe (Luer Slip or Luer Lock). The MicronJet 600 is a sterile, single use device.
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