Clearance Summary
SMOKE-EVAC received FDA 510(k) clearance under submission number K981888, sponsored by Bio-Medical Devices, Inc.. 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 1998-10-15.
- Submission: K981888
- Applicant / Sponsor: Bio-Medical Devices, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 1998-10-15
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.