The following data is part of a premarket notification filed by C.g.h. Medical, Inc. with the FDA for Gambro Polyflux Ii Hemodialyzerialyzer Hemodiafilter.
| Device ID | K933818 |
| 510k Number | K933818 |
| Device Name: | GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | C.G.H. MEDICAL, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Jeffrey R Shideman, Phd. |
| Correspondent | Jeffrey R Shideman, Phd. C.G.H. MEDICAL, INC. 1185 OAK ST. 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 | 1993-08-04 |
| Decision Date | 1995-01-25 |