Clearance Summary
HF-100 DIALYZER received FDA 510(k) clearance under submission number K802092, sponsored by Bio-Med 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 1980-12-18.
- Submission: K802092
- Applicant / Sponsor: Bio-Med Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1980-12-18
Classification & Regulation
This clearance is catalogued under FDA product code FJI and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.