The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Gambro Polyflux 6l, Gambro Polyflux 8l, Gambro Polyflux 10l, Model 6l, 8l, 10l.
| Device ID | K010985 |
| 510k Number | K010985 |
| Device Name: | GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO RENAL PRODUCTS 10810 W. COLLINS AVE. Lakewood, CO 80215 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman GAMBRO RENAL PRODUCTS 10810 W. COLLINS AVE. Lakewood, CO 80215 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-02 |
| Decision Date | 2001-10-10 |