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510(k) Data Aggregation

    K Number
    K021098
    Device Name
    DAUM-LECTRIC MRI DRILLING MACHINE
    Date Cleared
    2002-12-03

    (243 days)

    Product Code
    Regulation Number
    874.4250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MRI DEVICES DAUM GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Daum p-lectric Drilling Machine is a piezoelectrically driven hand held drill intended to assist the surgeon to access bony tissue. The Daum p-lectric Drilling Machine can drill into hard and soft bone tissue to create a small hole or to obtain bony tissue samples. The Daum p-lectric Drilling Machine is designed to be used inside or close to an MRI Unit up to 1.5 Tesla.
    Device Description
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