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510(k) Data Aggregation

    K Number
    K990332
    Device Name
    DUMEX IODOFORM PACKING STRIP
    Manufacturer
    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
    Date Cleared
    1999-04-14

    (70 days)

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

    DUMEX IODOFORM PACKING STRIP

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

    FOR GENERAL USE - DN AS DRADABADA No 2 WOND AACK WOUND MANAGEMENT CONDUIT IN

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance for any medical device. The documents are FDA 510(k) clearance letters and related forms for a "Dumex Iodoform Packing Strip." These documents confirm that the device is substantially equivalent to legally marketed predicate devices and allow it to be marketed, but they do not detail performance studies or acceptance criteria.

    Therefore, I cannot provide the requested information based on the given input.

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