The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Alwall Gfs 11,12,plus 12 Hollow Fiber Dialy.
| Device ID | K892523 |
| 510k Number | K892523 |
| Device Name: | GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | GAMBRO, INC. 460 MCLAWS CIRCLE, SUITE 200 Williamsburg, VA 23185 |
| Contact | Jeffrey Shideman |
| Correspondent | Jeffrey Shideman GAMBRO, INC. 460 MCLAWS CIRCLE, SUITE 200 Williamsburg, VA 23185 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-11 |
| Decision Date | 1989-05-11 |