The following data is part of a premarket notification filed by Cobe Renal Care, Inc. with the FDA for Cobe Centrysystem 600 Hg Hemodialyzers.
| Device ID | K960474 |
| 510k Number | K960474 |
| Device Name: | COBE CENTRYSYSTEM 600 HG HEMODIALYZERS |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | COBE RENAL CARE, INC. 1185 OAK ST. Lakewood, CO 80215 -4407 |
| Contact | Jeffrey R Shiderman |
| Correspondent | Jeffrey R Shiderman COBE RENAL CARE, INC. 1185 OAK ST. Lakewood, CO 80215 -4407 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-02 |
| Decision Date | 1996-08-14 |
| Summary: | summary |