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510(k) Data Aggregation

    K Number
    K980791
    Device Name
    DUMEX PAK-ITS WOVEN RIBBON PACKING
    Manufacturer
    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
    Date Cleared
    1998-04-29

    (58 days)

    Product Code
    EFQ,EFO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DUMEX PAK-ITS WOVEN RIBBON PACKING

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

    The Dumex Pak-its-Woven Ribbon Packing is intended to absorb exudate from discharging wounds into a secondary dressing. The packing is indicated for the following exudating wounds: minor cuts, abrasions and incisions. The packing may also be used on infected wounds under the care of a health care professional.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the "Dumex Pak-its Woven Ribbon Packing" device, outlining its substantial equivalence to a predicate device and its intended use and limitations.

    Therefore, I cannot fulfill your request to describe acceptance criteria and a study based on the given input.

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