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510(k) Data Aggregation

    K Number
    K071178
    Device Name
    OTOMEDICS SOFT TYMPANOSTOMY TUBE
    Manufacturer
    OTOMEDICS ADVANCED MEDICAL TECHNOLOGIES, LTD.
    Date Cleared
    2007-06-22

    (56 days)

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

    OTOMEDICS ADVANCED MEDICAL TECHNOLOGIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Otomedics Soft Tympanostomy Tube is a device that is intended to be implanted for ventilation or drainage of the middle ear.
    Device Description
    The Otomedics STT is a single flexible tube made of silicone rubber. The internal shape of the shaft is conical with T-shaped external flanges.
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