The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Blood Concentrator Sets 16,60,200.
| Device ID | K854309 |
| 510k Number | K854309 |
| Device Name: | GAMBRO BLOOD CONCENTRATOR SETS 16,60,200 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Contact | Jeffrey Shideman |
| Correspondent | Jeffrey Shideman 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 | 1985-10-25 |
| Decision Date | 1985-12-13 |