The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Centrysystem Hollow Fiber Dialyzers.
| Device ID | K881811 |
| 510k Number | K881811 |
| Device Name: | COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Mary L Armstrong |
| Correspondent | Mary L Armstrong COBE LABORATORIES, 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 | 1988-04-28 |
| Decision Date | 1988-09-15 |