The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for 95 C/1.5 Citric Acid Heat Processing Of Polysulfone Dialyzers.
| Device ID | K974090 |
| 510k Number | K974090 |
| Device Name: | 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS |
| Classification | Hemodialyzer, Re-use, Low Flux |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
| Contact | Tom Folden |
| Correspondent | Tom Folden FRESENIUS MEDICAL CARE NORTH AMERICA 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
| Product Code | MSE |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-29 |
| Decision Date | 1998-08-27 |
| Summary: | summary |