The following data is part of a premarket notification filed by C.g.h. Medical, Inc. with the FDA for Gambro Lundia Alpha Hemodialyzers.
| Device ID | K915504 |
| 510k Number | K915504 |
| Device Name: | GAMBRO LUNDIA ALPHA HEMODIALYZERS |
| Classification | Dialyzer, Parallel Flow |
| Applicant | C.G.H. MEDICAL, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Vera Buffaloe |
| Correspondent | Vera Buffaloe C.G.H. MEDICAL, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Product Code | FJG |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-09 |
| Decision Date | 1992-03-06 |