Clearance Summary
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS received FDA 510(k) clearance under submission number K060942, sponsored by Bob J. Johnson & Associates. 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 2006-07-07.
- Submission: K060942
- Applicant / Sponsor: Bob J. Johnson & Associates
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 2006-07-07
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.