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510(k) Data Aggregation

    K Number
    K140782
    Device Name
    ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR
    Manufacturer
    CELLERATION, INC.
    Date Cleared
    2014-08-13

    (135 days)

    Product Code
    NRB
    Regulation Number
    878.4410
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR

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

    MIST Systems produce a low energy ultrasound-generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of fibrin, yellow slough, tissue exudates and bacteria.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) summary for the UltraMIST System, a low energy ultrasound-generated mist device used for wound cleansing and maintenance debridement. This document is a regulatory approval letter from the FDA and does not contain the information requested regarding acceptance criteria, study details, or performance data of the device.

    Therefore, I cannot provide a response to your request as the necessary information is not present in the given document.

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