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510(k) Data Aggregation

    K Number
    K032644
    Device Name
    KOLPEXIN SPHERE
    Manufacturer
    ADAMED LTD.
    Date Cleared
    2004-05-28

    (275 days)

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

    ADAMED LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The KOLPEXIN™ Sphere is a vaginal pessary that is indicated for the conservative management of vaginal prolapse and pelvic floor muscular weakness.
    Device Description
    The KOLPEXIN* Sphere is symmetrically circular shaped with an attached nylon string for device removal. The device is made from medical grade polycarbonate, LEXAN 144R-111, GE Plastics, and is available in six sizes; 44mm, 42mm, 39mm, 36mm, 32mm and 28mm.
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