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510(k) Data Aggregation

    K Number
    K091298
    Device Name
    LUBREASE FEMALE LUBRICANT
    Manufacturer
    CURVES LIMITED
    Date Cleared
    2010-02-24

    (296 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CURVES LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Lubrease is a personal lubricant for vaginal application, intended to moisturise and lubricate to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is NOT compatible with latex or synthetic condoms
    Device Description
    Lubrease is a single use applicator containing 1.6ml water based lubricating gel. The applicator is designed to lock after the gel has been applied to prevent inadvertent re-use of the applicator.
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