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

    LUVENA VAGINAL MOISTURIZER & LUBRICANT

    K Number: K162235 · Decision Mar 24, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    242
    Applicant Total
    5
    Review Days
    227

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    Basic Information

    Device Name
    LUVENA VAGINAL MOISTURIZER & LUBRICANT
    K Number
    K162235
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Laclede, Inc.
    Date Received
    August 9, 2016
    Decision Date
    March 24, 2017
    Product Code
    NUC
    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
    NUC Lubricant, Personal

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