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510(k) Data Aggregation

    K Number
    K140305
    Device Name
    CAYA CONTOURED DIAPHRAGM
    Manufacturer
    KESSEL MEDINTIM GMBH
    Date Cleared
    2014-08-26

    (200 days)

    Product Code
    HDW
    Regulation Number
    884.5350
    Why did this record match?
    Applicant Name (Manufacturer) :

    KESSEL MEDINTIM GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Caya® contoured diaphragm is indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception. It is recommended for use with a contraceptive gel.
    Device Description
    The Caya® contoured diaphragm is a contoured, flexible, single-sized, silicone elastomer cup for covering the cervix that is circumscribed by a rim encapsulating a nylon spring. The Caya contoured diaphragm has an anatomically shaped spring that has been designed to fit women representing a range of traditional diaphragm sizes.
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