The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Alwall Gfs Plus 11, 16 & 20 Hollow Fiber.
| Device ID | K902481 |
| 510k Number | K902481 |
| Device Name: | GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | GAMBRO, INC. 460 MCLAWS CIRCLE, SUITE 200 Williamsburg, VA 23185 |
| Contact | Jeffrey Shideman,phd |
| Correspondent | Jeffrey Shideman,phd 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 | 1990-06-05 |
| Decision Date | 1990-07-27 |