510(k) K070623
K070623 is an FDA 510(k) premarket notification submitted by Pharmapac, LLC for the device "PHARMAPAC LUBRICATING JELLY". The FDA issued a decision of Substantially Equivalent on Aug 31, 2007. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300. Pharmapac, LLC has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 31, 2007
- Date Received
- Mar 6, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
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.