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510(k) Data Aggregation

    K Number
    K110166
    Device Name
    CLEARCUT S SAFETY KNIFE
    Manufacturer
    ALCON RESEARCH, LTD.
    Date Cleared
    2011-05-20

    (120 days)

    Product Code
    HNN
    Regulation Number
    886.4350
    Why did this record match?
    Product Code :

    HNN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ClearCut™ S Incisional Instruments are sterile, single-use disposable devices intended for use during ophthalmic surgical procedures.
    Device Description
    The ClearCut™ S family of incisional instruments are manual ophthalmic surgical instruments used by surgeons to create surgical incisions during ophthalmic surgical procedures. Incisional instruments incorporating sharps protection features provide injury prevention to those who come in contact with the device. The instruments are designed with an integral guard that can be activated to place the blade in a safe or exposed condition. The product is delivered to the user terminally sterilized by either gamma irradiation or ethylene oxide sterilization methods.
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