The following data is part of a premarket notification filed by Delmed, Inc. with the FDA for Delmed 80/2 Dialysis System W/ultrafiltration.
| Device ID | K901477 |
| 510k Number | K901477 |
| Device Name: | DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | DELMED, INC. 4090 PIKE LN. Concord, CA 94520 |
| Contact | Thomas E Cane |
| Correspondent | Thomas E Cane 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 | 1990-03-27 |
| Decision Date | 1990-07-27 |