The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Alwall Gfe 11 & 15 Hollow Fiber Dialyzers.
| Device ID | K880083 |
| 510k Number | K880083 |
| Device Name: | GAMBRO ALWALL GFE 11 & 15 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 | 1988-01-27 |