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510(k) Data Aggregation

    K Number
    K982558
    Device Name
    BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE
    Manufacturer
    BD/PREEFIL
    Date Cleared
    2000-03-08

    (595 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K952645
    Predicate For
    K011967,K011982
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Maintain patency of vascular devices

    Device Description

    Sterile Plastic Luer Lock Syringes of various sizes Filled with sterile saline

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for Preefil® Normal Saline Flush Syringes, focusing on its substantial equivalence to a predicate device and its intended use. It does not detail specific performance metrics, studies, or evaluation methodologies beyond the comparison with another flush device. Therefore, I cannot generate the requested table and information.

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