The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Lundia Pro 3 & 5 Dialyzer.
| Device ID | K853406 |
| 510k Number | K853406 |
| Device Name: | GAMBRO LUNDIA PRO 3 & 5 DIALYZER |
| Classification | Dialyzer, Parallel Flow |
| Applicant | GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Product Code | FJG |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-12 |
| Decision Date | 1986-01-08 |