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510(k) Data Aggregation
K Number
K192204Device Name
Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant,
Manufacturer
Date Cleared
2019-11-19
(97 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Valencia Naturals Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sensuva Personal Lubricants are personal lubricants, for penile, anal 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. These products are compatible with natural latex, polyisoprene, and polyurethane condoms.
Device Description
The Sensuva Personal Lubricants are water-based, non-sterile personal lubricants for over-the-counter use, formulated to be slightly cloudy and odorless. The device is designed to supplement the body's own natural lubrication and is compatible for use with natural rubber latex, polyurethane, and polyisoprene condoms during intimate sexual activity. Sensuva Personal Lubricants are neither a contraceptive nor a spermicide.
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