The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Fresenius 2008 Touch Panel Control Dialysis System.
| Device ID | K890824 |
| 510k Number | K890824 |
| Device Name: | FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM |
| Classification | System, Dialysate Delivery, Single Patient |
| Applicant | FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
| Contact | Thomas E Cane |
| Correspondent | Thomas E Cane FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
| Product Code | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-17 |
| Decision Date | 1989-05-11 |