The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Fresenius Art Hemoadsorption System.
| Device ID | K050273 |
| 510k Number | K050273 |
| Device Name: | FRESENIUS ART HEMOADSORPTION SYSTEM |
| Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02420 -9192 |
| Contact | Janet Kay |
| Correspondent | Janet Kay FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02420 -9192 |
| Product Code | LKN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-07 |
| Decision Date | 2005-06-08 |
| Summary: | summary |