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510(k) Data Aggregation

    K Number
    K962032
    Device Name
    KARL STORZ TWIN TRANSILLUMINATOR
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1996-07-05

    (42 days)

    Product Code
    MQW
    Regulation Number
    874.4350
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    Product Code :

    MQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are designed to transilluminate sinus tissue during ENT procedures.
    Device Description
    The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are manual, reusable, nonsterile medical devices. The body contact materials of these devices have a long history of biocompatibility with medical devices.
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