The following data is part of a premarket notification filed by Fresenius/delmed, Inc. with the FDA for 90/2 Peritoneal Dialysis System Dispos Cycler Set.
| Device ID | K903869 |
| 510k Number | K903869 |
| Device Name: | 90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | FRESENIUS/DELMED, INC. 4090 PIKE LN. Concord, CA 94520 |
| Contact | Thomas I Folden |
| Correspondent | Thomas I Folden FRESENIUS/DELMED, INC. 4090 PIKE LN. Concord, CA 94520 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-22 |
| Decision Date | 1990-11-20 |