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    K Number
    K171673
    Device Name
    Focus Cap
    Manufacturer
    GCE Medical Corporation
    Date Cleared
    2018-01-19

    (227 days)

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

    GCE Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Focus Cap has been designed to be attached to the distal end of a colonoscope. The Focus Cap is intended for the following: * For use in keeping the suitable depth of the colonoscope's field of view.
    Device Description
    The GCE Focus Cap has the shape of a short transparent tube which is attached to the distal end of the colonoscope. The Focus Cap is designed to facilitate the scope's view during colonoscopy procedures.
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