Clearance Summary
PRE-VA VAGINAL LUBRICANT received FDA 510(k) clearance under submission number K072741, sponsored by Ingfertility, LLC. 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 2008-07-16.
- Submission: K072741
- Applicant / Sponsor: Ingfertility, LLC
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2008-07-16
Classification & Regulation
This clearance is catalogued under FDA product code PEB and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.