Clearance Summary
Revaree Plus Vaginal Suppositories received FDA 510(k) clearance under submission number K213220, sponsored by Farma-Derma S.R.L.. 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 2022-06-21.
- Submission: K213220
- Applicant / Sponsor: Farma-Derma S.R.L.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2022-06-21
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.