Clearance Summary
Repagyn vaginal suppositories received FDA 510(k) clearance under submission number K153372, 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 2016-06-30.
- Submission: K153372
- 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: 2016-06-30
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.