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

    ONE PERSONAL LUBRICANT (WATER BASED)

    K Number: K110691 · Decision Feb 1, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    242
    Applicant Total
    2
    Review Days
    327

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    Basic Information

    Device Name
    ONE PERSONAL LUBRICANT (WATER BASED)
    K Number
    K110691
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    One
    Date Received
    March 11, 2011
    Decision Date
    February 1, 2012
    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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    Other Clearances by One

    K Number Device Name
    K110690 ONE PERSONAL LUBRICANT (SILICONE)