The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Polyflux 130 And 160 Hemodialyzer.
| Device ID | K871108 |
| 510k Number | K871108 |
| Device Name: | GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Contact | Jeffrey Shideman,phd |
| Correspondent | Jeffrey Shideman,phd GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-19 |
| Decision Date | 1987-05-15 |