The following data is part of a premarket notification filed by Sartorius Filters, Inc. with the FDA for Sartorius Aquasart Sm 40035 - Dialysate Sys.
| Device ID | K850435 |
| 510k Number | K850435 |
| Device Name: | SARTORIUS AQUASART SM 40035 - DIALYSATE SYS |
| Classification | Subsystem, Proportioning |
| Applicant | SARTORIUS FILTERS, INC. 26575 CORPORATE AVE. Hayward, CA 94545 |
| Contact | Steven Cates |
| Correspondent | Steven Cates SARTORIUS FILTERS, INC. 26575 CORPORATE AVE. Hayward, CA 94545 |
| Product Code | FKR |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-04 |
| Decision Date | 1985-06-04 |