Clearance Summary
AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2 received FDA 510(k) clearance under submission number K864821, sponsored by Reichert-Jung, 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 1987-02-10.
- Submission: K864821
- Applicant / Sponsor: Reichert-Jung, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4760
- Decision date: 1987-02-10
Classification & Regulation
This clearance is catalogued under FDA product code EOB and 21 CFR 874.4760, within the Ear, Nose, Throat review panel as a Class II device.