The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Fresenius 2008 Bss Bedside Dialysis System.
| Device ID | K890329 |
| 510k Number | K890329 |
| Device Name: | FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM |
| Classification | System, Dialysate Delivery, Single Pass |
| 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 | FIL |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-23 |
| Decision Date | 1989-05-11 |