Clearance Summary
FDS INTIMATE AND INTIMATE WARMING LUBRICANT received FDA 510(k) clearance under submission number K060145, sponsored by Alberto-Culver USA, Inc.. 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 2006-04-14.
- Submission: K060145
- Applicant / Sponsor: Alberto-Culver USA, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2006-04-14
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.