The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Meridian Hemodialysis Machine, Model 5m5576.
| Device ID | K992894 |
| 510k Number | K992894 |
| Device Name: | MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | Robert L Wilkinson |
| Correspondent | Robert L Wilkinson BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD 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 | 1999-08-27 |
| Decision Date | 1999-11-24 |
| Summary: | summary |