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

    GENDER CHOICE INFORMATION KIT, FEMALE AND MALE

    K Number: K870999 · Decision Jul 14, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    125

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    Basic Information

    Device Name
    GENDER CHOICE INFORMATION KIT, FEMALE AND MALE
    K Number
    K870999
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Procare C/O Wiley, Rein & Fielding
    Date Received
    March 11, 1987
    Decision Date
    July 14, 1987
    Product Code
    LHD
    Advisory Committee
    Unknown
    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
    LHD Device, Fertility Diagnostic, Proceptive

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