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510(k) Data Aggregation

    K Number
    K973510
    Device Name
    DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)
    Manufacturer
    IMMUNO-U.S., INC.
    Date Cleared
    1997-12-08

    (83 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMMUNO-U.S., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Duploject® is intended for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site. The Duploject® is equipped with a syringe holder, which assures controlled, accurate dispensing, and a needle holder, which allows the contents of the syringes to mix prior to dispensing.
    Device Description
    The Duploject® is a single-use, disposable syringe, which is used in the application of two nonhomogenous fluids or solutions onto a surgical site. The Duploject® consists of two disposable syringes and withdrawal needles for reconstitution of the solutions. It also contains the following components for use in the simultaneous application of the two solutions: a clip, with a common plunger, is used to join the two identical disposable syringes together and ensures that equal volumes of the two components are fed through a common joining piece and mixed prior to dispensing. Three extra application needles and one extra joining piece are included in the package to use as replacements, if needed. The Duploject® is sterile and non-pyrogenic.
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