Clearance Summary
EXTRACORPOREAL'S MODEL EX-85 DIALYZER received FDA 510(k) clearance under submission number K791961, sponsored by Extracorporeal Medical Specialities, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1979-11-13.
- Submission: K791961
- Applicant / Sponsor: Extracorporeal Medical Specialities, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1979-11-13
Classification & Regulation
This clearance is catalogued under FDA product code FJG and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.