Clearance Summary
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS received FDA 510(k) clearance under submission number K014169, sponsored by Bob J. Johnson & Assoc., 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 2002-02-06.
- Submission: K014169
- Applicant / Sponsor: Bob J. Johnson & Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 2002-02-06
Classification & Regulation
This clearance is catalogued under FDA product code FIP and 21 CFR 876.5665, within the Gastroenterology, Urology review panel as a Class II device.