Clearance Summary
COONS SOFT STENT received FDA 510(k) clearance under submission number K830483, sponsored by Medi-Tech, 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 1983-03-09.
- Submission: K830483
- Applicant / Sponsor: Medi-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 1983-03-09
Classification & Regulation
This clearance is catalogued under FDA product code FGE and 21 CFR 876.5010, within the Gastroenterology, Urology review panel as a Class II device.