The following data is part of a premarket notification filed by Gambro Renal Products, Inc. with the FDA for Polyflux 14l, 17l, 21l Hemodialyzer/filter Labeled For Single Use.
| Device ID | K040255 |
| 510k Number | K040255 |
| Device Name: | POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO RENAL PRODUCTS, INC. 10810 W. COLLINS AVE. Lakewood, CO 80215 |
| Contact | Jean Willey |
| Correspondent | Jean Willey GAMBRO RENAL PRODUCTS, INC. 10810 W. COLLINS AVE. Lakewood, CO 80215 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-04 |
| Decision Date | 2004-05-24 |
| Summary: | summary |