Clearance Summary
Pre-Seed Fertility Lubricant received FDA 510(k) clearance under submission number K193450, sponsored by Church & Dwight Co., 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 2020-07-23.
- Submission: K193450
- Applicant / Sponsor: Church & Dwight Co., Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2020-07-23
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.