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510(k) Data Aggregation

    K Number
    K994340
    Device Name
    CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ
    Manufacturer
    HAI LABORATORIES, INC.
    Date Cleared
    2000-09-20

    (272 days)

    Product Code
    HLI, NQE
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAI LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clinical Specular Microscope Model HAI CL-1000xyz is intended to be used to examine the cornea of the eye.
    Device Description
    Clinical Specular Microscope, Model HAI CL-1000xyz
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