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510(k) Data Aggregation

    K Number
    K082138
    Device Name
    AIRGENT, MODEL AG7000010
    Manufacturer
    PERFACTION, INC.
    Date Cleared
    2009-01-23

    (178 days)

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

    PERFACTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Airgent™ System is a needle-free injection system designed for the administration of various medicines and vaccines to the body by means of a high velocity jet of fluid that penetrates the skin. The Airgent™ includes a disposable delivery kit intended for multiple injections on a single patient. The Airgent™ System is indicated for professional use only.
    Device Description
    The Airgent" System is an automated, multi-use, needless injector system, intended to deliver medications and vaccines to the body by a highly accelerated pneumatically powered jet of fluid via a very small entry point in the surface of the skin The system is comprised of a console and single-use sterile injector kit The user may control the dosage (150ul/200ul) and system pressure for the injection via the graphical user interface on the front panel of the console The entire injector kit is replaced between patients and may be used for multiple injections per patient
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