The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Fresenius F Series Hemoconcentrators F400,f500,f700,f800,f400ts,f500ts,f700s,f800ts.
| Device ID | K974584 |
| 510k Number | K974584 |
| Device Name: | FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
| Contact | Virginia Singer |
| Correspondent | Virginia Singer 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 | 1997-12-08 |
| Decision Date | 1998-05-14 |
| Summary: | summary |