The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Biopure Dialysate Concentrate Mix Syst/concentrate.
| Device ID | K930181 |
| 510k Number | K930181 |
| Device Name: | BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE |
| Classification | System, Dialysate Delivery, Single Patient |
| Applicant | FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
| Contact | Scott N Walker |
| Correspondent | Scott N Walker FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
| Product Code | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-14 |
| Decision Date | 1995-11-29 |