Clearance Summary
SHARPLAN SMOKE EVACUATION UNIT, MODEL 100 received FDA 510(k) clearance under submission number K894765, sponsored by Laser Industries , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1989-09-28.
- Submission: K894765
- Applicant / Sponsor: Laser Industries , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5070
- Decision date: 1989-09-28
Classification & Regulation
This clearance is catalogued under FDA product code FYD and 21 CFR 878.5070, within the General, Plastic Surgery review panel as a Class II device.