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510(k) Data Aggregation

    K Number
    K131176
    Device Name
    ROSS RU SKIN DISCONTINUITIES
    Manufacturer
    BIOTD, S.A.
    Date Cleared
    2014-05-12

    (382 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K082333
    Why did this record match?
    Device Name :

    ROSS RU SKIN DISCONTINUITIES

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

    An over-the-counter (OTC) product for topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations.

    Device Description

    Ross Ru is a wound dressing gel that helps maintain a moist wound environment that is conducive to healing, by either absorbing or donating the moisture and wound exudates and may inhibit the growth of microorganisms within the dressing. Ross Ru Skin Discontinuities is supplied in a collapsible low density polyethylene tube sealed at one end and fitted with a dispensing orifice at the other end accessible by the removal of its screw cap.

    AI/ML Overview

    The provided 510(k) summary for "Ross Ru Skin Discontinuities" does not include information about acceptance criteria or a study proving the device meets said criteria, as it is for a wound gel and not an AI/ML powered device. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and a comparison of characteristics.

    Therefore, I cannot extract the information required for your request regarding AI/ML device performance, as it is not present in the provided text.

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