Clearance Summary
FIBER OPTIC LIGHT SOURCE received FDA 510(k) clearance under submission number K902784, sponsored by Trek Medical Products, 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 1990-09-12.
- Submission: K902784
- Applicant / Sponsor: Trek Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4350
- Decision date: 1990-09-12
Classification & Regulation
This clearance is catalogued under FDA product code EQH and 21 CFR 874.4350, within the Ear, Nose, Throat review panel as a Class I device.