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    K Number
    K970178
    Device Name
    CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM
    Manufacturer
    CORPAK, INC.
    Date Cleared
    1997-07-21

    (185 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM

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

    The intended use of the Clog Zapper™ Enteral Feeding Tube Decloging System is to clear certain types of blockages, primarily and of of offecal is to crear certain types of blockages, primal enteral formulations, which may occur in enteral feeding tubes.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details for the "Clog Zapper™ Enteral Feeding Tube Declogging System."

    The document is a 510(k) clearance letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and good manufacturing practices. It also includes the "Indications For Use" statement.

    Therefore, I cannot fulfill your request for the specific information you listed.

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