Clearance Summary
KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS received FDA 510(k) clearance under submission number K040196, sponsored by Tyco Healthcare/Kendall. 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 2004-05-05.
- Submission: K040196
- Applicant / Sponsor: Tyco Healthcare/Kendall
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2004-05-05
Classification & Regulation
This clearance is catalogued under FDA product code LZH and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.