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510(k) Data Aggregation

    K Number
    K171239
    Device Name
    TULA Tube Delivery System
    Manufacturer
    Tusker Medical
    Date Cleared
    2017-06-28

    (62 days)

    Product Code
    ETD
    Regulation Number
    874.3880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tusker Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tula Tube Delivery System is intended to provide a means to create a myringotomy with insertion of a preloaded Grommet type tympanostomy tube.
    Device Description
    The Tula Tube Delivery System (TDS) is a device that penetrates the tympanic membrane and inserts the Grommet type tympanostomy tube with a button controlled activation. It is intended to provide a means to create a myringotomy with insertion of a preloaded grommet type tympanostomy tube.
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