The following data is part of a premarket notification filed by Fresenius/delmed, Inc. with the FDA for Fresenius/delmed 90/2 Peritoneal Dialysis System.
| Device ID | K902149 |
| 510k Number | K902149 |
| Device Name: | FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | FRESENIUS/DELMED, INC. 4090 PIKE LN. Concord, CA 94520 |
| Contact | Thomas E Cane |
| Correspondent | Thomas E Cane FRESENIUS/DELMED, INC. 4090 PIKE LN. Concord, CA 94520 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-15 |
| Decision Date | 1990-10-30 |