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510(k) Data Aggregation

    K Number
    K012071
    Device Name
    ENT LASERVISION
    Manufacturer
    UNION MEDICAL USA
    Date Cleared
    2001-12-03

    (154 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNION MEDICAL USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ENT LaserVision is a device to be used in conjunction with the UN-L25 CO2 Laser in The ENI Laser Vision is a device to be used far computer membrane and Myringotomy .
    Device Description
    Laser Otoscope, Device Model: ENT LaserVision
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