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510(k) Data Aggregation

    K Number
    K093508
    Device Name
    RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)
    Manufacturer
    WOMANCARE GLOBAL
    Date Cleared
    2010-03-04

    (112 days)

    Product Code
    HGH, CAN
    Regulation Number
    884.5070
    Why did this record match?
    Applicant Name (Manufacturer) :

    WOMANCARE GLOBAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For uterine aspiration/uterine evacuation in obstetric and gynecological patients. Indications for use are rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy.
    Device Description
    The Rigid Cannulae are injection molded plastic devices approximately 190mm in length, made from a styrenic copolymer manufactured in sizes 6mm. 7mm. 8mm. 9mm. 10mm, 11mm, and 12mm (outer diameter), straight and curved.
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