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

    Sage 2-in-1 Personal Lubricant and Moisturizer

    K Number: K190150 · Decision Jul 16, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    242
    Applicant Total
    2
    Review Days
    167

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    Basic Information

    Device Name
    Sage 2-in-1 Personal Lubricant and Moisturizer
    K Number
    K190150
    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
    January 30, 2019
    Decision Date
    July 16, 2019
    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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