Clearance Summary
COBE ACUFLEX FSN, #15-208 received FDA 510(k) clearance under submission number K820237, sponsored by Cobe Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1982-03-10.
- Submission: K820237
- Applicant / Sponsor: Cobe Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 1982-03-10
Classification & Regulation
This clearance is catalogued under FDA product code LFK and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.