Clearance Summary
DIALYIS START CARE KIT received FDA 510(k) clearance under submission number K802361, sponsored by Med-Pak Corp.. 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 1981-01-16.
- Submission: K802361
- Applicant / Sponsor: Med-Pak Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5820
- Decision date: 1981-01-16
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.