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 |