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    K Number
    K082818
    Device Name
    SUBCUTANEOUS NEEDLE INFUSION SET
    Manufacturer
    MARCAL MEDICAL, INC.
    Date Cleared
    2008-12-23

    (89 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARCAL MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Subcutaneous Infusion Set is designed specifically for the delivery of medication to the subcutaneous tissue
    Device Description
    The subcutaneous needle infusion set consists of a sterile packaged kit including the infusion set and an adhesive dressing to hold the device in place. The unique Single, Bifurcated, Trifurcated, and Quadfurcated for the Sub-Q have a luer lock at one end and a 90 degree needle mounted to a butterfly stabilizer at the other end. The sets are convenient to use, associated with less trauma, and offer an opportunity to improve compliance cost-effectively through the use of a dedicated infusion set. The device is for single use only.
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