The following data is part of a premarket notification filed by Cobe Renal Care, Inc. with the FDA for Gambro Hc 14r Hemoconcentrator.
| Device ID | K951311 |
| 510k Number | K951311 |
| Device Name: | GAMBRO HC 14R HEMOCONCENTRATOR |
| 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 Shideman |
| Correspondent | Jeffrey R Shideman 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 | 1995-03-22 |
| Decision Date | 1996-01-11 |