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    K Number
    K051630
    Device Name
    SUPER VIEW DISPOSABLE BIOM LENS SET
    Manufacturer
    INSIGHT INSTRUMENTS, INC.
    Date Cleared
    2005-06-29

    (12 days)

    Product Code
    HJK
    Regulation Number
    886.1385
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSIGHT INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Allow visualization of the ocular fundus, vitreous, and retinal structures during vitreoretinal surgery.
    Device Description
    The Super View Disposable BIOM Lens Set(s) consists of multiple sterile, disposable, thermoplastic lenses for both contact and non-contact use in conjunction with an operating microscope equipped with a BIOM wide-angle viewing system.
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