510(k) K180219
K180219 is an FDA 510(k) premarket notification submitted by United Consortium for the device "JO H2O Flavored Personal Lubricants". The FDA issued a decision of Substantially Equivalent on April 20, 2018. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300. United Consortium has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 2018
- Date Received
- January 25, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lubricant, Personal
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type
This device is a personal lubricant, for penile and/or 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 may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.