The following data is part of a premarket notification filed by Gambro Renal Care Products with the FDA for Gambro Polyflux, Model 140h, 170h, 210h.
| Device ID | K030592 |
| 510k Number | K030592 |
| Device Name: | GAMBRO POLYFLUX, MODEL 140H, 170H, 210H |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO RENAL CARE PRODUCTS 10810 W. COLLINS AVE. Lakewood, CO 80215 |
| Contact | Jeffrey R Schidman |
| Correspondent | Jeffrey R Schidman GAMBRO RENAL CARE 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 | 2003-02-25 |
| Decision Date | 2003-05-23 |
| Summary: | summary |