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510(k) Data Aggregation

    K Number
    K022068
    Device Name
    TUBING, DIALYSATE (AND CONNECTOR)
    Manufacturer
    MOLDED PRODUCTS INC.
    Date Cleared
    2002-09-23

    (90 days)

    Product Code
    FID
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TUBING, DIALYSATE (AND CONNECTOR)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MPC-740: The MPC-740 is a Male to Male Dialysate Connection Connector. It may be used to connect the MPC-725 to the Dialysis machine Dialysate Line in order to extend the length of the Dialysate Tubing. May also be used as a recirculation connector; connecting both dialysis machine Dialysate lines together.
    MPC-725: The MPC-725 is a Female to Female Dialysate Connection Connector. When connected to the MPC-740 (which has been connected to the dialysis machines' dialysate line) this line may be used to extend the length of the Dialysis Machine Dialysate Line. The MPC-725 may also be used to connect one Dialyzer Port to another Dialyzer Port.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding "Dialysate Tubing with Connectors MPC-725 and MPC-740". This document is an approval letter for a medical device and does not contain information related to acceptance criteria, device performance, or a study proving its conformance.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, not on clinical or performance study results.

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