Clearance Summary
ANESTHESIA TRAY, CAUDAL received FDA 510(k) clearance under submission number K780120, sponsored by Kendall Research Center. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1978-02-06.
- Submission: K780120
- Applicant / Sponsor: Kendall Research Center
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5140
- Decision date: 1978-02-06
Classification & Regulation
This clearance is catalogued under FDA product code CAZ and 21 CFR 868.5140, within the Anesthesiology review panel as a Class II device.