Clearance Summary
CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS received FDA 510(k) clearance under submission number K910906, sponsored by Tri-State Hospital Supply Corp.. 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 1991-04-01.
- Submission: K910906
- Applicant / Sponsor: Tri-State Hospital Supply Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1991-04-01
Classification & Regulation
This clearance is catalogued under FDA product code FPK and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.