The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Bicarb-o-mate Hemodialysis Sod. Bicarb..
| Device ID | K802465 |
| 510k Number | K802465 |
| Device Name: | BICARB-O-MATE HEMODIALYSIS SOD. BICARB. |
| Classification | Subsystem, Proportioning |
| Applicant | RENAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKR |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-09 |
| Decision Date | 1980-11-12 |