The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Fresenius Dialysate Acid Concentrate.
| Device ID | K922088 |
| 510k Number | K922088 |
| Device Name: | FRESENIUS DIALYSATE ACID CONCENTRATE |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
| Contact | Scott N Waler |
| Correspondent | Scott N Waler FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-04 |
| Decision Date | 1994-10-17 |