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    K Number
    K973294
    Device Name
    INNOVATOME MICROKERATOME
    Manufacturer
    INNOVATIVE OPTICS, INC.
    Date Cleared
    1997-10-03

    (31 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVATIVE OPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INNOVATOME™ microkeratome is indicted for the resection of a circular anterior lamellar flap.
    Device Description
    The INNOVATOME™ is a microkeratome that rotates at 14,000 rpm and is capable of creating lamella with diameters ranging from 8-10 mm.
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