The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Gf-80-m, Gf-80-h Hemodialyzer.
| Device ID | K820304 |
| 510k Number | K820304 |
| Device Name: | GAMBRO GF-80-M, GF-80-H HEMODIALYZER |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | GAMBRO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-04 |
| Decision Date | 1982-03-02 |