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510(k) Data Aggregation

    K Number
    K992655
    Device Name
    FERTILOSCOPY KIT FH 1.29/FTO 1.40
    Manufacturer
    SOPRANE S.A.
    Date Cleared
    2000-03-13

    (217 days)

    Product Code
    HEWHETHIH
    Regulation Number
    884.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOPRANE S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fertiloscopy Kit is intended to be used for transvaginal hydro-laparoscopy, dye-test, salpingoscopy, and hysteroscopy during one procedure. The device is indicated for use in the diagnosis of tubo-peritoneal infertility.
    Device Description
    The Fertiloscopy Kit has the same general intended use and similar principles of operation and technological characteristics as a combination of Circon's cleared THL, Cook's cleared IBA Catheter, Imagyn's cleared MicroSpan, and Origin's cleared Blunt Tip Trocar.
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