The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low Vol Hemoconcentrator W/tubing Set F3000ts.
| Device ID | K992275 |
| 510k Number | K992275 |
| Device Name: | FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | FRESENIUS USA, INC. 110 MASON CR Concord, CA |
| Contact | Virginia Singer |
| Correspondent | Virginia Singer FRESENIUS USA, INC. 110 MASON CR Concord, CA |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-07 |
| Decision Date | 1999-08-04 |
| Summary: | summary |