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510(k) Data Aggregation

    K Number
    K161483
    Device Name
    Unger Quad Injector
    Manufacturer
    STRADIS HEALTHCARE
    Date Cleared
    2016-10-31

    (153 days)

    Product Code
    LCJ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRADIS HEALTHCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Unger Quad Injector is intended to be used as the needle infusion set component of a tissue expander fill kit for breast tissue expanders designed to be filled with sterile saline using 21-gauge needles. Specifically, the Unger Quad Injector is indicated for assisting the clinician in delivery of sterile saline into the surgically-placed, sub-dermal, temporary, removable tissue expander.
    Device Description
    The Unger Quad Injector is a 'needle infusion set' component to a breast tissue expander fill kit. The device is comprised of four 21 gauge hypodermic lumen needles, which are connected to a needle hub, a luer adapter and tubing.
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