The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Cahp High Performance Cellulose Diacetate (capillary, Hollow Fiber).
| Device ID | K970654 |
| 510k Number | K970654 |
| Device Name: | CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) |
| Classification | Hemodialyzer, Re-use, Low 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 | MSE |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-21 |
| Decision Date | 1997-11-12 |
| Summary: | summary |