Clearance Summary
MICRO-SP CUSTOM SPINAL ANESTHESIA TRAY received FDA 510(k) clearance under submission number K934526, sponsored by Neurodelivery Technology, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1994-01-28.
- Submission: K934526
- Applicant / Sponsor: Neurodelivery Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5140
- Decision date: 1994-01-28
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.