The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Alwall Gfe 12 & 18 Hollow Fiber Dialyzer.
| Device ID | K883589 |
| 510k Number | K883589 |
| Device Name: | GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Contact | R Shideman |
| Correspondent | R Shideman 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 | 1988-08-22 |
| Decision Date | 1988-09-29 |