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510(k) Data Aggregation

    K Number
    K141504
    Device Name
    T-8000 THEROZONE UNIT
    Date Cleared
    2015-02-24

    (263 days)

    Product Code
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    THEROZONE USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The T-8000 TherOzone Unit is intended for the reduction of microorganisms in dental unit water lines.
    Device Description
    The T-8000 TherOzone Unit is a device intended to clean dental unit water lines. The device consists of an ozone generator and dispensing bottles.
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