Clearance Summary
DUREX PLAY SOFT & SENSUAL LUBRICANT received FDA 510(k) clearance under submission number K071626, sponsored by Ssl Americas. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2008-04-01.
- Submission: K071626
- Applicant / Sponsor: Ssl Americas
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2008-04-01
Classification & Regulation
This clearance is catalogued under FDA product code NUC and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.