Clearance Summary
LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET received FDA 510(k) clearance under submission number K873435, sponsored by Level 1 Technologies, 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 1987-10-05.
- Submission: K873435
- Applicant / Sponsor: Level 1 Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1987-10-05
Classification & Regulation
This clearance is catalogued under FDA product code KOD and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.