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510(k) Data Aggregation

    K Number
    K140305
    Device Name
    CAYA CONTOURED DIAPHRAGM
    Date Cleared
    2014-08-26

    (200 days)

    Product Code
    Regulation Number
    884.5350
    Why did this record match?
    Product Code :

    HDW

    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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    K Number
    K080040
    Device Name
    ORTHO ALL-FLEX DIAPHRAGM
    Date Cleared
    2008-08-25

    (231 days)

    Product Code
    Regulation Number
    884.5350
    Why did this record match?
    Product Code :

    HDW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ORTHO® ALL-FLEX® Diaphragm, in conjunction with an appropriate spermicide, is indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception.
    Device Description
    The ORTHO® ALL-FLEX® Diaphragm (arcing spring), is a molded, buff-colored, shallow silicone rubber cup with a flexible rubber covered spring rim. The ORTHO® ALL-FLEX® Diaphragm vaginal diaphragm contains a distortion-free, dual spring-within-a-spring that provides unique arcing action no matter where the rim is compressed. It is appropriate for use not only where ordinary diaphragms are indicated, but also in patients with mild cystocele, rectocele or retroversion.
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    K Number
    K063223
    Device Name
    MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS
    Date Cleared
    2008-01-23

    (456 days)

    Product Code
    Regulation Number
    884.5350
    Why did this record match?
    Product Code :

    HDW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Milex Wide-Seal Silicone Diaphragms, in conjunction with an approved spermicidal gel or cream are indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception.
    Device Description
    The Milex Wide-Seal contraceptive diaphragm is a shallow cup with a flexing rim. The diaphragm is composed of silicone. The diaphragm is placed over the cervix and coated with spermicidal cream or gel to prevent pregnancy. The diagrams are offered in the following sizes: 60mm, 65mm, 70mm, 75mm, 80mm, 85mm, 90mm, 95mm. The diaphragms are offered in two styles: Omniflex (Flat or Coil Style that folds in one place only) and Arcing (Folds in any place to form an arc or bow for insertion).
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