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510(k) Data Aggregation

    K Number
    K972455
    Device Name
    JIMMY JOHN III RECTAL NOZZEL, MODEL CIT
    Manufacturer
    COLON THERAPEUTICS
    Date Cleared
    1997-09-09

    (70 days)

    Product Code
    KPL
    Regulation Number
    876.5220
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    JIMMY JOHN III RECTAL NOZZEL, MODEL CIT

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

    Intended for use in Colon Irrigation with any colon irrigation system.

    Class II - These devices are intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.

    Device Description

    JIMMY JOHN III RECTAL NOZZLE MODEL CIT

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the "JIMMY JOHN III RECTAL NOZZLE MODEL CIT." This document does not contain information about acceptance criteria or a study proving that a device meets those criteria, as it pertains to a physical medical device (rectal nozzle) rather than a software-based AI/ML device.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details from these documents.

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