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510(k) Data Aggregation
K Number
K191411Device Name
Ah!Yes Ob Coco Personal Lubricant
Manufacturer
Date Cleared
2020-02-06
(254 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Bio-Tech Lubricants Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
AH! YES® OB COCO: A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. AH! YES® OB COCO is not compatible with natural rubber latex, polyurethane or polyisoprene condoms.
Device Description
AH! YES OB COCO is a non-sterile, plant-oil based personal lubricant that consists primarily of sunflower oil and fractionated coconut oil and is not compatible with condoms. It is neither a contraceptive nor a spermicide. The formulation is an opaque paste that melts at body temperature. The product is packaged in a polyethylene single use applicator.
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