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510(k) Data Aggregation

    K Number
    K093725
    Device Name
    CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C
    Manufacturer
    CANADA ENDOSCOPE CORPORATION
    Date Cleared
    2010-08-30

    (270 days)

    Product Code
    FAJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CANADA ENDOSCOPE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Like the predicated devices, the Canada Endoscope is used to visualize the urinary tract for diagnostic and therapeutic procedures.
    Device Description
    The Canada Endoscope is a rigid type endoscope with a compact objectives and a developed rod-lens system. The basic design of the Canada Endoscope is similar to those legally available for sale in the USA. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The fiber optics (light carrying fibers) are located between these tubes. The inner tube of the body contains the rod-lens system.
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