The following data is part of a premarket notification filed by Renal Solutions, Inc. with the FDA for Allient Sorbet Hemodialysis System, Model 1100.
| Device ID | K060381 |
| 510k Number | K060381 |
| Device Name: | ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 |
| Classification | System, Dialysate Delivery, Sorbent Regenerated |
| Applicant | RENAL SOLUTIONS, INC. 770 COMMONWEALTH DR. Warrendale, PA 15086 |
| Contact | David J Vanella |
| Correspondent | David J Vanella RENAL SOLUTIONS, INC. 770 COMMONWEALTH DR. Warrendale, PA 15086 |
| Product Code | FKT |
| CFR Regulation Number | 876.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-14 |
| Decision Date | 2006-05-24 |
| Summary: | summary |