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510(k) Data Aggregation

    K Number
    K971004
    Device Name
    MEDCORP FLOW I.V. REGULATOR EXTENSION SET
    Manufacturer
    MEDCORP INTL.
    Date Cleared
    1997-10-02

    (197 days)

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

    MEDCORP INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To provide fluid path connection and flow regulation from fluid delivery set to venipuncture device.
    Device Description
    The device is a sterile, nonpyrogenic, single use, I.V. extension set which has flexible tubing that connects to a fluid delivery system by a Luer lock connector, a flow regulator, and flexible tubing that connects to a venipuncture device by a Luer lock connector. A Y-site on the lower length of tubing allows for infusion of medication below the regulator.
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