510(k) K141718
K141718 is an FDA 510(k) premarket notification submitted by Combe Incorporated for the device "INTERNAL HYDRATING GEL". The FDA issued a decision of Substantially Equivalent on Nov 13, 2014. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300. Combe Incorporated has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 13, 2014
- Date Received
- Jun 25, 2014
- 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.