The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gf 120m, 120h, 180m & 180h Hollow Fiber Dialyzers.
| Device ID | K880084 |
| 510k Number | K880084 |
| Device Name: | GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Contact | Jeffrey Shideman,phd |
| Correspondent | Jeffrey Shideman,phd GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-12 |
| Decision Date | 1988-02-19 |