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510(k) Data Aggregation

    K Number
    K210814
    Device Name
    Coconu Water Based Personal Lubricant
    Manufacturer
    Date Cleared
    2021-06-14

    (89 days)

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

    Coconu, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Coconu Water Based Personal Lubricant is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    Coconu Water Based Personal Lubricant is a non-sterile, water-based personal lubricant that is intended for penile and vaginal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. Its formulation consists of water, Coconut) fruit juice, Microcare SB (water, sodium benzoate, potassium sorbate), Keltrol CG (xanthan gum), Purac FCC 50 (water, lactic acid), Geogard 111S (sodium dehydroacetate), CMC 7H3SF PHARM (sodium carboxymethylcellulose). Coconu Water Based Personal Lubricant is packaged in a MDPE (medium density polyethylene) 3 oz tube, packaged in an outer box. Coconu Water Based Personal Lubricant is a personal lubricant for over-the-counter (OTC) use.
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