The following data is part of a premarket notification filed by Pure Water Solutions, Inc. with the FDA for Pure Water Solutions Central Water System For Hemodialysis.
| Device ID | K011005 |
| 510k Number | K011005 |
| Device Name: | PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS |
| Classification | Subsystem, Water Purification |
| Applicant | PURE WATER SOLUTIONS, INC. 3925 WEST NORTHSIDE DR. Jackson, MS 39209 |
| Contact | John Bower |
| Correspondent | John Bower PURE WATER SOLUTIONS, INC. 3925 WEST NORTHSIDE DR. Jackson, MS 39209 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-04 |
| Decision Date | 2002-11-01 |