Clearance Summary
HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM received FDA 510(k) clearance under submission number K080966, sponsored by Aoti , 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 2008-08-06.
- Submission: K080966
- Applicant / Sponsor: Aoti , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5650
- Decision date: 2008-08-06
Classification & Regulation
This clearance is catalogued under FDA product code KPJ and 21 CFR 878.5650, within the General, Plastic Surgery review panel as a Class II device.