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510(k) Data Aggregation
K Number
K051668Device Name
THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT
Manufacturer
Date Cleared
2005-07-08
(16 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
GOODMARK USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Art of Intimacy Response" ™ Liquid Personal lubricant is principally intended as personal lubricant to supplement the body's natural lubricating fluids, and to enhance the ease and comfort of intimate sexual activity with or without a latex condom.
Device Description
The Art of Intimacy Response ™ is a homogenous blend of fluids. It is specifically formulated to be a clear, non-irritating, non-staining, non-greasy, medium viscosity liquid gel and is compatible for use with or without a latex condom during intimate sexual activity as evidenced by condom compatibility testing. The Art of Intimacy Response ™ is not a contraceptive or spermicide, nor does it contain any such component.
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