510(k) K062535
K062535 is an FDA 510(k) premarket notification submitted by Mcneil-Ppc, Inc. for the device "K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING". The FDA issued a decision of Substantially Equivalent on Jan 26, 2007. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300. Mcneil-Ppc, Inc. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 26, 2007
- Date Received
- Aug 29, 2006
- 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
- 510(k)
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.