The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Psn Hemodialyzer, Model Psn 130, 150, 170, 210.
| Device ID | K001685 |
| 510k Number | K001685 |
| Device Name: | PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 |
| Classification | Hemodialyzer, Re-use, Low Flux |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD., MPR-A2E Mcgaw Park, IL 60085 -6730 |
| Contact | Robert L Wilkinson |
| Correspondent | Robert L Wilkinson BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD., MPR-A2E Mcgaw Park, IL 60085 -6730 |
| Product Code | MSE |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-01 |
| Decision Date | 2000-11-15 |