The following data is part of a premarket notification filed by C.g.h. Medical, Inc. with the FDA for Gambro Engstrom Y Filter Pkg. Alone W/ Var.models.
| Device ID | K915154 |
| 510k Number | K915154 |
| Device Name: | GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS |
| Classification | Regulator, Pressure, Gas Cylinder |
| Applicant | C.G.H. MEDICAL, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman C.G.H. MEDICAL, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Product Code | CAN |
| CFR Regulation Number | 868.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-14 |
| Decision Date | 1992-05-27 |