Clearance Summary
MODEL 5460 + 5480 POP-OFF VALVES received FDA 510(k) clearance under submission number K802591, sponsored by G. Dundas Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1980-11-12.
- Submission: K802591
- Applicant / Sponsor: G. Dundas Co.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5160
- Decision date: 1980-11-12
Classification & Regulation
This clearance is catalogued under FDA product code BSZ and 21 CFR 868.5160, within the Anesthesiology review panel as a Class II device.