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510(k) Data Aggregation

    K Number
    K092739
    Device Name
    MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE
    Manufacturer
    C-LINK MICRO IMAGING, INC
    Date Cleared
    2010-01-12

    (126 days)

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

    C-LINK MICRO IMAGING, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or an incision.
    Device Description
    Like the predicate devices, the C-Link Microendoscope Model S-0001 Single Light Source and D-0001 Dual Light Source consist of a semi-rigid fiberscope with a separate irrigating outer sheath or introducer to view and assess/biopsy soft tissue.
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