The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Gambro Polyflux 6 Lr, 8 Lr And 10 Lr.
| Device ID | K023615 |
| 510k Number | K023615 |
| Device Name: | GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR |
| Classification | Hemodialyzer, Re-use, High Flux |
| 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 | MSF |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-28 |
| Decision Date | 2003-05-06 |
| Summary: | summary |