Clearance Summary
STA-SET I.V. FLOW REGULATOR received FDA 510(k) clearance under submission number K880006, sponsored by Controlled Flow , Ltd.. 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 1988-03-24.
- Submission: K880006
- Applicant / Sponsor: Controlled Flow , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1988-03-24
Classification & Regulation
This clearance is catalogued under FDA product code LDR and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.