The following data is part of a premarket notification filed by Gambro Healthcare with the FDA for Cobe Centrysystem 700 Hg Hemodialyzer.
| Device ID | K962427 |
| 510k Number | K962427 |
| Device Name: | COBE CENTRYSYSTEM 700 HG HEMODIALYZER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO HEALTHCARE 1185 OAK ST. Lakewood, CO 80215 -4498 |
| Contact | Jeffrey R Shideman, Ph.d. |
| Correspondent | Jeffrey R Shideman, Ph.d. GAMBRO HEALTHCARE 1185 OAK ST. Lakewood, CO 80215 -4498 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-24 |
| Decision Date | 1996-09-20 |
| Summary: | summary |