The following data is part of a premarket notification filed by C.g.h. Medical, Inc. with the FDA for Cobe Centrysystem Cs500 Dialyzer.
| Device ID | K941708 |
| 510k Number | K941708 |
| Device Name: | COBE CENTRYSYSTEM CS500 DIALYZER |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| 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 | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-06 |
| Decision Date | 1995-05-12 |