The following data is part of a premarket notification filed by Dialysis Services, Inc. with the FDA for Dialysis Services Water Treatment & Distribution System.
| Device ID | K043344 |
| 510k Number | K043344 |
| Device Name: | DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM |
| Classification | Subsystem, Water Purification |
| Applicant | DIALYSIS SERVICES, INC. 3620 KELTON JACKSON RD. Springfield, TN 37172 |
| Contact | Mike Sterling |
| Correspondent | Mike Sterling DIALYSIS SERVICES, INC. 3620 KELTON JACKSON RD. Springfield, TN 37172 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-06 |
| Decision Date | 2005-03-23 |
| Summary: | summary |