The following data is part of a premarket notification filed by Cobe Renal Care, Inc. with the FDA for Gambro Lundia 94-500 Dialyzer.
| Device ID | K945746 |
| 510k Number | K945746 |
| Device Name: | GAMBRO LUNDIA 94-500 DIALYZER |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | COBE RENAL CARE, INC. 1185 OAK ST. Lakewood, CO 80215 -4407 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman COBE RENAL CARE, INC. 1185 OAK ST. Lakewood, CO 80215 -4407 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-23 |
| Decision Date | 1995-09-08 |