The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Psn Dialyzer, Model Psn 130/r5m4233, Model Psn-150/r5m4234.
| Device ID | K980658 |
| 510k Number | K980658 |
| Device Name: | PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| 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 | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-19 |
| Decision Date | 1998-05-19 |
| Summary: | summary |