Clearance Summary
MAC LEE VAGINAL IRRIGATOR received FDA 510(k) clearance under submission number K841710, sponsored by Mac Lee Medical Products. 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 1984-06-19.
- Submission: K841710
- Applicant / Sponsor: Mac Lee Medical Products
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5900
- Decision date: 1984-06-19
Classification & Regulation
This clearance is catalogued under FDA product code HED and 21 CFR 884.5900, within the Obstetrics/Gynecology review panel as a Class I device.