Clearance Summary
PERFADEX WITH THAM received FDA 510(k) clearance under submission number K081997, sponsored by Vitrolife Sweden AB. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2008-10-09.
- Submission: K081997
- Applicant / Sponsor: Vitrolife Sweden AB
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5880
- Decision date: 2008-10-09
Classification & Regulation
This clearance is catalogued under FDA product code MSB and 21 CFR 876.5880, within the Gastroenterology, Urology review panel as a Class II device.