The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Plasmafiltration System.
| Device ID | K850621 |
| 510k Number | K850621 |
| Device Name: | GAMBRO PLASMAFILTRATION SYSTEM |
| Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| 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 | 1985-02-15 |
| Decision Date | 1985-05-16 |