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510(k) Data Aggregation
K Number
K042915Device Name
O'MY NATURAL LUBRICANT, O'MY NATURAL FLAVORED LUBRICANT
Manufacturer
Date Cleared
2005-08-31
(314 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
O'MY PRODUCTS INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Patient Lubricants are devices intended to lubricate a body orifice to facilitate entry of a device. When used as an accessory to a condom, patient lubricants are deemed Class II Medical Devices. O'My Lubricant and O'My Flavored Lubricants are principally intended as personal lubricants to supplement the body's own natural lubrication fluids. O'My Lubricants also reduce friction enhancing the comfort and ease of intimate sensual activity with or without a latex condom. O'My Lubricant and O'My Flavored Lubricants are also recommended for personal lubrication when dryness causes discomfort.
Device Description
O'My Lubricant and O'My Flavored Lubricants are non-sterile, water-based personal lubricants designed to supplement the body's natural lubrication fluids. The formula is a clear, non-greasy natural liquid gel.
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