The following data is part of a premarket notification filed by Renal Solutions Inc. with the FDA for Allient Sorbent Hemodialysis System, Model# 1500.
| Device ID | K070739 |
| 510k Number | K070739 |
| Device Name: | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 |
| Classification | System, Dialysate Delivery, Sorbent Regenerated |
| Applicant | RENAL SOLUTIONS INC. 770 COMMONWEALTH DRIVE SUITE 101 Warrendale, PA 15086 |
| Contact | David J Vanella |
| Correspondent | David J Vanella RENAL SOLUTIONS INC. 770 COMMONWEALTH DRIVE SUITE 101 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 | 2007-03-16 |
| Decision Date | 2007-05-25 |