Clearance Summary
EASY-JET DEVICE received FDA 510(k) clearance under submission number K972383, sponsored by A.Stein - Regulatory Affairs Consulting. 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 1999-11-23.
- Submission: K972383
- Applicant / Sponsor: A.Stein - Regulatory Affairs Consulting
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3850
- Decision date: 1999-11-23
Classification & Regulation
This clearance is catalogued under FDA product code KLZ and 21 CFR 874.3850, within the Ear, Nose, Throat review panel as a Class II device.