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510(k) Data Aggregation

    K Number
    K083791
    Device Name
    CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S
    Manufacturer
    CORPAK MEDSYSTEMS
    Date Cleared
    2009-03-04

    (75 days)

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

    CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S

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

    The CORFLO Anti-I.V. Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to any enteral feeding device acccepting a standard enteral step connector. The CORFLO Anti-IV Enteral Feeding Extension Set is for pediatric and neonatal use only.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "CORFLO Anti-I.V. Enteral Feeding Extension Set Model # 20-1060AIV-S." This document describes the FDA's determination of substantial equivalence to a predicate device, allowing the product to be marketed.

    However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.

    The letter is a regulatory approval document, not a scientific study report. Therefore, I cannot extract the requested information from the provided text.

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