The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Lundia Major High Flux Hemodialyz.
| Device ID | K801480 |
| 510k Number | K801480 |
| Device Name: | GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-24 |
| Decision Date | 1980-08-27 |