The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Ct Celluloser Triacetate Hollow Fiber Dialyzer (ct-110g/ct-190g).
| Device ID | K970663 |
| 510k Number | K970663 |
| Device Name: | CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) |
| Classification | Hemodialyzer, Re-use, High Flux |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAULKEGAN RD. Mcgaw Park, IL 60085 -6730 |
| Contact | Robert L Wilkinson |
| Correspondent | Robert L Wilkinson BAXTER HEALTHCARE CORP. 1620 WAULKEGAN RD. Mcgaw Park, IL 60085 -6730 |
| Product Code | MSF |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-21 |
| Decision Date | 1998-01-11 |