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510(k) Data Aggregation

    K Number
    K011928
    Device Name
    HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Date Cleared
    2001-08-10

    (51 days)

    Product Code
    FPA,GCJ
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05

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

    THE HYDROTOWER® ARTHROSCOPIC ADMINISTRATION TUBING SET IS USED TO MOVE FLUID FROM THE TOWER BAG TO THE PATIENT.

    Device Description

    The Hydrotower® Arthroscopic Administration Tubing Set is designed to be used with the Nortech® Hydrotower® System. The device is comprised of pvc tubing, check valve, a pressure relief valve, and numerous polymer fittings.

    AI/ML Overview

    The provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for the Hydrotower® Arthroscopic Administration Tubing Set, which primarily focuses on establishing substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested table or answer the questions related to the study design, sample sizes, expert qualifications, or comparative effectiveness.

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