The following data is part of a premarket notification filed by Gambro Renal Products, Inc. with the FDA for Phoenix Hemodialysis Delivery System.
| Device ID | K103832 |
| 510k Number | K103832 |
| Device Name: | PHOENIX HEMODIALYSIS DELIVERY SYSTEM |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO RENAL PRODUCTS, INC. 14143 DENVER WEST PARKWAY SUITE 400 Lakewood, CO 80401 |
| Contact | Kae Miller |
| Correspondent | Kae Miller GAMBRO RENAL PRODUCTS, INC. 14143 DENVER WEST PARKWAY SUITE 400 Lakewood, CO 80401 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-30 |
| Decision Date | 2011-05-20 |
| Summary: | summary |