The following data is part of a premarket notification filed by Gambro Healthcare with the FDA for Gambro Polyflux 17r, Capillary Dialyzer/ Filter.
| Device ID | K994390 |
| 510k Number | K994390 |
| Device Name: | GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER |
| Classification | Hemodialyzer, Re-use, High Flux |
| Applicant | GAMBRO HEALTHCARE 1185 OAK ST. Lakewood, CO 80215 -4498 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman GAMBRO HEALTHCARE 1185 OAK ST. Lakewood, CO 80215 -4498 |
| Product Code | MSF |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-28 |
| Decision Date | 2000-10-26 |
| Summary: | summary |