Clearance Summary
COIL DIALYSIS, MODELS DM-360 AND DM-360- received FDA 510(k) clearance under submission number K790382, sponsored by Estracorporeal, 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 1979-05-02.
- Submission: K790382
- Applicant / Sponsor: Estracorporeal, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1979-05-02
Classification & Regulation
This clearance is catalogued under FDA product code FKD and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.