Clearance Summary
Three Way Stop Cock received FDA 510(k) clearance under submission number K223499, sponsored by M/S Romsons International. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2023-07-21.
- Submission: K223499
- Applicant / Sponsor: M/S Romsons International
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2023-07-21
Classification & Regulation
This clearance is catalogued under FDA product code FMG and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.