The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Xenium Dialyzer, Models 110, 130, 150, 170, 190 And 210.
| Device ID | K062079 |
| 510k Number | K062079 |
| Device Name: | XENIUM DIALYZER, 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 MPGR-AL Mcgaw Park, IL 60085 |
| Contact | David E Curtin |
| Correspondent | David E Curtin BAXTER HEALTHCARE CORPORATION 1620 WAUKEGAN ROAD MPGR-AL Mcgaw Park, IL 60085 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-21 |
| Decision Date | 2006-10-19 |
| Summary: | summary |