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510(k) Data Aggregation

    K Number
    K192779
    Device Name
    Bunny Wax Personal Lubricant
    Manufacturer
    Reoxcyn, LLC
    Date Cleared
    2020-06-02

    (246 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Bunny Wax Personal Lubricant is a personal lubricant indicated for penile and/or vaginal application intended to lubricate and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding the substantial equivalence determination for a medical device (Bunny Wax Personal Lubricant). It does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding AI/ML algorithm performance.

    Therefore, I cannot extract the requested information to fill in the table or answer the specific questions about a study and AI/ML performance. The document focuses on regulatory approval based on equivalence to predicate devices, not on performance metrics of an AI system.

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