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510(k) Data Aggregation

    K Number
    K132313
    Device Name
    PESSARY
    Manufacturer
    EIS CORPORATION
    Date Cleared
    2014-12-05

    (498 days)

    Product Code
    HHW
    Regulation Number
    884.3575
    Why did this record match?
    Applicant Name (Manufacturer) :

    EIS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EIS Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women
    Device Description
    The subject device is a silicone vaqinal pessary. The submission includes the following designs: cube, dish, donut, marland, oval, gellhorn, gellhorn short, shaatz, and ring.
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