The following data is part of a premarket notification filed by Renal Solutions, Inc. with the FDA for Allient Sorbent Hemodialysis System, Model 1000.
| Device ID | K043574 |
| 510k Number | K043574 |
| Device Name: | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 |
| Classification | System, Dialysate Delivery, Sorbent Regenerated |
| Applicant | RENAL SOLUTIONS, INC. 700 COMMONWEALTH DR SUITE 101 Warrendale, PA 15086 |
| Contact | Richard Confer |
| Correspondent | Richard Confer RENAL SOLUTIONS, INC. 700 COMMONWEALTH DR SUITE 101 Warrendale, PA 15086 |
| Product Code | FKT |
| CFR Regulation Number | 876.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-27 |
| Decision Date | 2005-06-03 |
| Summary: | summary |