The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Lundia 10-1l, 1n, 1h, 3h, 4n, 4h, 5h, 6n.
| Device ID | K862840 |
| 510k Number | K862840 |
| Device Name: | GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N |
| Classification | Dialyzer, Parallel Flow |
| Applicant | GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Contact | Jeffery R Shideman |
| Correspondent | Jeffery 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 | 1986-07-29 |
| Decision Date | 1986-09-29 |