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510(k) Data Aggregation

    K Number
    K121311
    Device Name
    THIXO-GEL ULTRASOUND SPRAY
    Date Cleared
    2012-08-30

    (121 days)

    Product Code
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLOVERLINE INTERNATIONAL PHARMA SERVICES GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Thixo-Gel Ultrasound Spray® is used as an ultrasound coupling medium for diagnostic and therapeutic procedures on external, intact skin for a short duration.
    Device Description
    Thixo-Gel Ultrasound Spray® is a colorless, thisotropic gel contained in a dispenser that allows it to be dispersed as a thin layer on external, intact skin.
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