Clearance Summary
TETLEY PATIENT ADMINISTRATION SET received FDA 510(k) clearance under submission number K913416, sponsored by Tetley Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1991-10-28.
- Submission: K913416
- Applicant / Sponsor: Tetley Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1390
- Decision date: 1991-10-28
Classification & Regulation
This clearance is catalogued under FDA product code IYT and 21 CFR 892.1390, within the Radiology review panel as a Class II device.