The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Fresenius Polysulfone Dialyzers.
| Device ID | K921134 |
| 510k Number | K921134 |
| Device Name: | FRESENIUS POLYSULFONE DIALYZERS |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
| Contact | Tom Folden |
| Correspondent | Tom Folden FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-10 |
| Decision Date | 1993-12-02 |