The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Lundia Ic-6h Parallel Plate Dialyzer.
| Device ID | K900918 |
| 510k Number | K900918 |
| Device Name: | GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO, INC. 460 MCLAWS CIRCLE, SUITE 200 Williamsburg, VA 23185 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman GAMBRO, INC. 460 MCLAWS CIRCLE, SUITE 200 Williamsburg, VA 23185 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-27 |
| Decision Date | 1990-07-16 |