Clearance Summary
Dilapan-S received FDA 510(k) clearance under submission number K143447, sponsored by Medicem Technology S.R.O. 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 2015-04-17.
- Submission: K143447
- Applicant / Sponsor: Medicem Technology S.R.O
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4260
- Decision date: 2015-04-17
Classification & Regulation
This clearance is catalogued under FDA product code PKN and 21 CFR 884.4260, within the Obstetrics/Gynecology review panel as a Class II device.