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    K Number
    K161298
    Device Name
    ShenDa Sinuscope
    Manufacturer
    SHENYANG SHENDA ENDOSCOPE CO., LTD
    Date Cleared
    2017-08-25

    (473 days)

    Product Code
    EOBJ02
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHENYANG SHENDA ENDOSCOPE CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ShenDa® Sinuscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.
    Device Description
    ShenDa® Sinuscope is an unchanneled endoscope intended to provide an endoscopic means to view the nasal cavity and nasopharynx. The endoscope is available in the various combination of outer diameter (2.7mm, 3mm, 4mm) and vision direction angles (0, 12, 30, 45, 70 and 90 degree). It can be connected to OLYMPUS light source and OLYMPUS light cable. It is a reusable device subject to cleaning and steam sterilization.
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