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

    CONCEIVEX LATEX-FREE SEMEN COLLECTOR

    K Number: K080752 · Decision May 14, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    58

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    Basic Information

    Device Name
    CONCEIVEX LATEX-FREE SEMEN COLLECTOR
    K Number
    K080752
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.5250
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Conceivex, Inc.
    Date Received
    March 17, 2008
    Decision Date
    May 14, 2008
    Product Code
    OBB
    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
    OBB Kit, Conception-Assist, Home Use

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