The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Centrysystem 145e,160e,175e,190e Dialyzers.
| Device ID | K864831 |
| 510k Number | K864831 |
| Device Name: | COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Vera Buffaloe |
| Correspondent | Vera Buffaloe 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 | 1986-12-09 |
| Decision Date | 1987-03-27 |