The following data is part of a premarket notification filed by Bob J. Johnson & Associates with the FDA for Water Purification Components For Hemodialysis.
| Device ID | K060942 |
| 510k Number | K060942 |
| Device Name: | WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS |
| Classification | Subsystem, Water Purification |
| Applicant | BOB J. JOHNSON & ASSOCIATES 16420 W. HARDY RD., STE. 100 Houston, TX 77060 |
| Contact | Jon Hulsey |
| Correspondent | Jon Hulsey BOB J. JOHNSON & ASSOCIATES 16420 W. HARDY RD., STE. 100 Houston, TX 77060 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-06 |
| Decision Date | 2006-07-07 |
| Summary: | summary |