Clearance Summary
ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 received FDA 510(k) clearance under submission number K000154, sponsored by E. Benson Hood Lab, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2000-03-29.
- Submission: K000154
- Applicant / Sponsor: E. Benson Hood Lab, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3620
- Decision date: 2000-03-29
Classification & Regulation
This clearance is catalogued under FDA product code FWN and 21 CFR 874.3620, within the Ear, Nose, Throat review panel as a Class II device.