Clearance Summary
ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN received FDA 510(k) clearance under submission number K844765, sponsored by Laser Spectrum, 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 1985-04-08.
- Submission: K844765
- Applicant / Sponsor: Laser Spectrum, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 1985-04-08
Classification & Regulation
This clearance is catalogued under FDA product code EWQ and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.