Clearance Summary
MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT received FDA 510(k) clearance under submission number K861045, sponsored by Sharplan Industries, 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 1986-04-23.
- Submission: K861045
- Applicant / Sponsor: Sharplan Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4500
- Decision date: 1986-04-23
Classification & Regulation
This clearance is catalogued under FDA product code LLO and 21 CFR 874.4500, within the Ear, Nose, Throat review panel as a Class II device.