The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Hemodialysis Concentrate, Sodiu.
| Device ID | K781967 |
| 510k Number | K781967 |
| Device Name: | HEMODIALYSIS CONCENTRATE, SODIU |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | RENAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-24 |
| Decision Date | 1978-12-07 |