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510(k) Data Aggregation

    K Number
    K992661
    Device Name
    CONTROL III ELITE
    Manufacturer
    MARIL PRODUCTS, INC.
    Date Cleared
    1999-09-14

    (36 days)

    Product Code
    LRJ
    Regulation Number
    880.6890
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARIL PRODUCTS, INC.

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

    Control III Elite is indicated for use in healthcare setting for environmental control of bacteria and viruses and the prevention of crosscontamination. Control III Elite is an intermediate level disinfectant. Active ingredients are a combination of quaternary ammonium chlorides requiring a 10-minute contact at 20° C. (68°F).

    Device Description

    Control III® Elite

    AI/ML Overview

    I am sorry, but based on the provided document, the information required to answer your request is not present. The document is a clearance letter from the FDA for a device called "Control III® Elite" and an "Indication For Use Statement." It does not contain details about acceptance criteria, specific studies, sample sizes, expert qualifications, or ground truth establishment for the device's performance evaluation.

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