Clearance Summary
CENTURION UMBILICAL CATHETER received FDA 510(k) clearance under submission number K942353, 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 1995-08-15.
- Submission: K942353
- Applicant / Sponsor: Tri-State Hospital Supply Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 1995-08-15
Classification & Regulation
This clearance is catalogued under FDA product code FOS and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.