The following data is part of a premarket notification filed by Dayton Water Systems with the FDA for Dayton Water Systems Ultrapure Water Treatment Systems For Hemodialysis.
| Device ID | K021352 |
| 510k Number | K021352 |
| Device Name: | DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS |
| Classification | Subsystem, Water Purification |
| Applicant | DAYTON WATER SYSTEMS 430 LEO ST. Dayton, OH 45404 |
| Contact | Dayne Gilleland |
| Correspondent | Dayne Gilleland DAYTON WATER SYSTEMS 430 LEO ST. Dayton, OH 45404 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-29 |
| Decision Date | 2002-08-01 |