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    K Number
    K980096
    Device Name
    OAC (OPTICAL ASPIRATING CURETTE)
    Manufacturer
    IMAGYN MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1998-05-01

    (112 days)

    Product Code
    HCY
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HCY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Optical Aspirating Curette is indicated for use in visualizing the interior of the uterus and obtaining an endometrial tissue sample adequate for histological evaluation.
    Device Description
    Imagyn's Optical Aspirating Curette consists of a disposable aspirating curette intended to remove tissue from the uterus and from the mucosal lining of the uterus by scraping and aspirating. The curette has a multi-lumen design that accommodates the introduction of Imagyn's reusable fiberoptic hysteroscope, which allows for visualization of the uterine cavity during the curettage procedure.
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