Clearance Summary
MASTEL LASER CLEAN ROOM, MODEL EBS-100 received FDA 510(k) clearance under submission number K043494, sponsored by Mastel Precision Surgical Instruments, 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 2005-10-04.
- Submission: K043494
- Applicant / Sponsor: Mastel Precision Surgical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5070
- Decision date: 2005-10-04
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.