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510(k) Data Aggregation
K Number
K190752Device Name
Satisfaite
Manufacturer
Date Cleared
2019-12-13
(263 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
FemmePharma Consumer Healthcare, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Satisfaite™ is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to supplement the body's natural lubrication, and to enhance the ease and comfort of intimate sexual activity. This product is compatible with natural rubber, latex, and polyisoprene condoms; and is not compatible with polyurethane condoms.
Device Description
Satisfaite™ is a topically applied, water-based personal lubricant for vaginal application, intended to moisturize and lubricate, and to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Satisfaite™ is self-administered to the user via a prefilled unit dose applicator for intravaginal administration. The device consists of the polypropylene plastic applicator pre-filled with the lubricant. The three main ingredients of the lubricant by percent weight are purified water, glycerin and propylene glycol. Each pre-filled applicator holds 1 gram of lubricant and is for a single use in a home environment. Each pre-filled applicator is individually over-wrapped with a disposable polypropylene sleeve and packaged 10 units to a cardboard box. The lubricant makes direct patient contact with the vaginal mucosa and has a contact duration of < 24 hours. The applicator also makes direct patient contact with the vaginal mucosa only at the time of application and is discarded after use.
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