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

    BabyDance Fertility Lubricant

    K Number: K162319 · Decision Apr 28, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    9
    Applicant Total
    2
    Review Days
    252

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    Basic Information

    Device Name
    BabyDance Fertility Lubricant
    K Number
    K162319
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fairhaven Health, LLC
    Date Received
    August 19, 2016
    Decision Date
    April 28, 2017
    Product Code
    PEB
    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
    PEB Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

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    Other Clearances by Fairhaven Health, LLC

    K Number Device Name
    K190150 Sage 2-in-1 Personal Lubricant and Moisturizer