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510(k) Data Aggregation

    K Number
    K172994
    Device Name
    EPI K Console
    Manufacturer
    Moria SA
    Date Cleared
    2017-10-26

    (29 days)

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

    Moria SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Epi-K is intended for use in the separation of the cornea in preparation for subsequent surgical procedures on denuded cornea.
    Device Description
    The Evolution 3E Console includes pumps for producing vacuum for use with a keratome in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on denuded cornea. The Evolution 3E Console power unit has been designed to operate the keratome by means of electric motor or turbine.
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