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    K Number
    K041239
    Device Name
    GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000
    Manufacturer
    GENESIS MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2004-11-08

    (181 days)

    Product Code
    KZE
    Regulation Number
    880.5430
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENESIS MEDICAL TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GMTI PharmaJet System is intended to deliver various predetermined medicines and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet which penetrates the surface of the skin and delivers the medicine or vaccine to the body.
    Device Description
    The Genesis Medical Technologies, Inc. (GMTI) PharmaJet Needle-free Injector System (PharmaJet System) is a compact, spring-loaded needle-free hypodermic injector system. The PharmaJet System consists of an injector, a cocking station and single-use, sterile, disposable vials.
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