Clearance Summary
LAMANO DIRECTORS received FDA 510(k) clearance under submission number K894592, sponsored by Marlo Surgical Technology. 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 1989-09-08.
- Submission: K894592
- Applicant / Sponsor: Marlo Surgical Technology
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1989-09-08
Classification & Regulation
This clearance is catalogued under FDA product code GCM and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.