The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Xenium Xph, Models 110, 130, 150, 170, 190 And 210.
| Device ID | K083778 |
| 510k Number | K083778 |
| Device Name: | XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | BAXTER HEALTHCARE CORPORATION 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | Diane Rennpferd |
| Correspondent | Diane Rennpferd BAXTER HEALTHCARE CORPORATION 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-19 |
| Decision Date | 2009-02-20 |
| Summary: | summary |