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510(k) Data Aggregation

    K Number
    K970888
    Device Name
    IOTEC TROCAR AND FLEXIBLE CANNULA
    Manufacturer
    IOTEC INDUSTRIES
    Date Cleared
    1998-01-09

    (304 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
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    Applicant Name (Manufacturer) :

    IOTEC INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The product is intended to create a point of entry for curved endoscopic instruments into the abdominal and chest cavities during a endoscopic procedure.
    Device Description
    The Iotec Trocar and Flexible Cannula is composed of Plastic, Stainless Steel (or plastic rod) for attachment of the trocar tip; and a flexible plastic cannula tube.
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