Clearance Summary
SUREBREATH DOME, E-Z BREATHER received FDA 510(k) clearance under submission number K915158, sponsored by Ipax, 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 1992-02-12.
- Submission: K915158
- Applicant / Sponsor: Ipax, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1992-02-12
Classification & Regulation
This clearance is catalogued under FDA product code GAD and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.