Clearance Summary
KITS AND TRAYS FOR DIALYSIS USE received FDA 510(k) clearance under submission number K871630, sponsored by Dove Medical Supplies. 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 1987-05-26.
- Submission: K871630
- Applicant / Sponsor: Dove Medical Supplies
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5820
- Decision date: 1987-05-26
Classification & Regulation
This clearance is catalogued under FDA product code FKG and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class I device.