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510(k) Data Aggregation

    K Number
    K970414
    Device Name
    CONFOCAL MICROSCOPE
    Manufacturer
    CON-S LTD.
    Date Cleared
    1997-07-15

    (173 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    CON-S LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Our device has the same indications for use as both the Tandem Scanning Instrument and as the Tomey Confocal microscope. These indications are to view ocular images, and evaluate ocular disease and infections in patients.
    Device Description
    CON-S LTD. CONFOCAL MICROSCOPE
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