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510(k) Data Aggregation

    K Number
    K960374
    Device Name
    ULTRACUT 2000
    Manufacturer
    ULTRALASE TECHNOLOGIES, INC.
    Date Cleared
    1996-06-28

    (154 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTRALASE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ultracut 2000 and CUSA are both ultrasonic surgical instruments intended for use to cut or fragment tissue, bone, or organs in orthopedic surgery.
    Device Description
    The Ultralase Ultracut 2000 is equivalent to the predicate device Cavitron Corporation's Cavitron Ultrasonic Surgical Aspirator (CUSA). The Ultracut 2000 has the same general intended use, similar principles of operation, and similar technological characteristics as The Ultracut 2000 and CUSA are both ultrasonic surgical the predicate device. instruments intended for use to cut or fragment tissue, bone, or organs in orthopedic surgery.
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