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510(k) Data Aggregation

    K Number
    K990935
    Device Name
    JACKSON ESOPHAGEAL DILATOR
    Manufacturer
    PILLING WECK SURGICAL
    Date Cleared
    1999-05-17

    (59 days)

    Product Code
    KNQ
    Regulation Number
    876.5365
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To be used for exploratory and dilation of strictures of the esophagus. Designed to be used in conjunction with an appropriate size rigid esophagascope.

    Device Description

    Device consists of silicone tip, stainless steel rod and nylon sleeve.

    AI/ML Overview

    The provided text is a 510(k) summary for the Jackson Esophageal Dilator. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

    Therefore, I cannot fulfill your request with the given input. The document focuses on regulatory classification and substantial equivalence to a predicate device, rather than detailed performance study results.

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