Clearance Summary
EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS received FDA 510(k) clearance under submission number K991719, sponsored by Medimex Holfeld GmbH & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1999-08-18.
- Submission: K991719
- Applicant / Sponsor: Medimex Holfeld GmbH & Co.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5140
- Decision date: 1999-08-18
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.