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    K Number
    K052919
    Device Name
    MICROSULIS TISSUE ABLATION SYSTEM
    Manufacturer
    MICROSULIS AMERICAS, INC.
    Date Cleared
    2006-01-13

    (88 days)

    Product Code
    NEY
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROSULIS AMERICAS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microsulis Tissue Ablation (MTA) System and accessories are for use in the intraoperative coagulation of soft tissue.
    Device Description
    The MTA surgical applicator is inserted into soft tissue and coagulates a volume of tissue surrounding the active The MTA Suglicator tip. Temperature probes are included in the applicator kits to determine the temperature at area of the applicator up. Temperature probos are included in the applicator is to be used with the MTA Sulis™ V the penpher you the obegalate manually set at the desired power levels by the operator.
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