Clearance Summary
KENDALL-LTP TURNER SAVE-A-LINE received FDA 510(k) clearance under submission number K003511, sponsored by The Ludlow Company LP. 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 2001-01-24.
- Submission: K003511
- Applicant / Sponsor: The Ludlow Company LP
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5680
- Decision date: 2001-01-24
Classification & Regulation
This clearance is catalogued under FDA product code FRP and 21 CFR 880.5680, within the General Hospital review panel as a Class I device.