Clearance Summary
UC-CARE WARMING SYSTEM received FDA 510(k) clearance under submission number K090978, sponsored by UC-CARE , 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 2009-08-10.
- Submission: K090978
- Applicant / Sponsor: UC-CARE , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4350
- Decision date: 2009-08-10
Classification & Regulation
This clearance is catalogued under FDA product code GEH and 21 CFR 878.4350, within the General, Plastic Surgery review panel as a Class II device.