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510(k) Data Aggregation
K Number
K230518Device Name
HydraDose Vaginal Suppositories
Manufacturer
Date Cleared
2023-06-23
(116 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
MD Labs LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HydraDose Vaginal Suppositories are a personal lubricant, for 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Device Description
HydraDose Vaginal Suppositories is a glyceride-based personal lubricant for over-thecounter use. The subject device is a non-sterile solid preparation containing hyaluronic acid, cocoa butter, triglycerides, and cera alba. The subject device is packaged in sets of five a polyvinyl chloride (PVC)/polyethylene (PE) blister pack. The lubricant is not compatible with natural rubber latex, polyisoprene condoms, and polyurethane condoms.
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