BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ORTHO ALL-FLEX DIAPHRAGM

    K Number: K080040 · Decision Aug 25, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    231

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    Basic Information

    Device Name
    ORTHO ALL-FLEX DIAPHRAGM
    K Number
    K080040
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5350
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Produtos Profissionais Ltda.
    Date Received
    January 7, 2008
    Decision Date
    August 25, 2008
    Product Code
    HDW
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HDW Diaphragm, Contraceptive (And Accessories)

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