The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Exeltra Plus High Flux Dialyzer, Model 210.
| Device ID | K030975 |
| 510k Number | K030975 |
| Device Name: | EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | David E Curtin |
| Correspondent | David E Curtin BAXTER HEALTHCARE CORP. 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 | 2003-03-28 |
| Decision Date | 2003-04-25 |
| Summary: | summary |