The following data is part of a premarket notification filed by Renal Solutions, Inc. with the FDA for Sorb+hisorb+cartridge.
| Device ID | K031099 |
| 510k Number | K031099 |
| Device Name: | SORB+HISORB+CARTRIDGE |
| Classification | System, Dialysate Delivery, Sorbent Regenerated |
| Applicant | RENAL SOLUTIONS, INC. 1010 MEADOWVIEW DR. Apollo, PA 15613 |
| Contact | Richard G Confer |
| Correspondent | Richard G Confer RENAL SOLUTIONS, INC. 1010 MEADOWVIEW DR. Apollo, PA 15613 |
| Product Code | FKT |
| CFR Regulation Number | 876.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-07 |
| Decision Date | 2003-09-17 |
| Summary: | summary |