The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Phoenix Hemodialysis Delivery System, Gambro Cartridge For Hemodialysis Blood Tubing Set.
| Device ID | K001156 |
| 510k Number | K001156 |
| Device Name: | PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO RENAL PRODUCTS 10810 W. COLLINS AVE. Lakewood, CO 80215 |
| Contact | Benita Bradford |
| Correspondent | Benita Bradford GAMBRO RENAL PRODUCTS 10810 W. COLLINS AVE. Lakewood, CO 80215 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-10 |
| Decision Date | 2000-07-07 |