The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Baxter Accura System, Model 5m5660.
| Device ID | K021615 |
| 510k Number | K021615 |
| Device Name: | BAXTER ACCURA SYSTEM, MODEL 5M5660 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD., MPR-A2E Mcgaw Park, IL 60085 -6730 |
| Contact | David E Curtin |
| Correspondent | David E Curtin BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD., MPR-A2E Mcgaw Park, IL 60085 -6730 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-16 |
| Decision Date | 2002-11-18 |
| Summary: | summary |