Clearance Summary
BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING received FDA 510(k) clearance under submission number K092903, sponsored by Maquet GmbH and Co. KG. 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 2009-12-01.
- Submission: K092903
- Applicant / Sponsor: Maquet GmbH and Co. KG
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 2009-12-01
Classification & Regulation
This clearance is catalogued under FDA product code BTA and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.