The following data is part of a premarket notification filed by Bob J. Johnson & Assoc., Inc with the FDA for Water Purification Components For Hemodialysis.
| Device ID | K014169 |
| 510k Number | K014169 |
| Device Name: | WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS |
| Classification | Subsystem, Water Purification |
| Applicant | BOB J. JOHNSON & ASSOC., INC 7715 MAINLAND DR. # 115 San Antonio,, TX 78250 |
| Contact | Robert Snyder |
| Correspondent | Robert Snyder BOB J. JOHNSON & ASSOC., INC 7715 MAINLAND DR. # 115 San Antonio,, TX 78250 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-19 |
| Decision Date | 2002-02-06 |
| Summary: | summary |