The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Psn Hemodialyzer, Models Psn 170, Psn 210.
Device ID | K001422 |
510k Number | K001422 |
Device Name: | PSN HEMODIALYZER, MODELS PSN 170, PSN 210 |
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 | Robert L Wilkinson |
Correspondent | Robert L Wilkinson 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-05-05 |
Decision Date | 2000-06-02 |