510(k) K053397
K053397 is an FDA 510(k) premarket notification submitted by Mcneil-Ppc, Inc. for the device "K-Y BRAND SENSUAL MIST". The FDA issued a decision of Substantially Equivalent on Feb 17, 2006. 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
- Feb 17, 2006
- Date Received
- Dec 6, 2005
- Clearance Type
- Special
- 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.