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

    JO Coconut Hybrid Cooling Personal Lubricant

    K Number: K232091 · Decision Oct 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    242
    Applicant Total
    12
    Review Days
    101

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    Basic Information

    Device Name
    JO Coconut Hybrid Cooling Personal Lubricant
    K Number
    K232091
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CC Wellness, LLC
    Date Received
    July 13, 2023
    Decision Date
    October 22, 2023
    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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    K210986 H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit
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    K200602 Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant
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