The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Granulyte Powder Dialysate Concentrate And Mixing.
| Device ID | K911459 |
| 510k Number | K911459 |
| Device Name: | GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
| Contact | Tom Folden |
| Correspondent | Tom Folden FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-03 |
| Decision Date | 1991-07-17 |