The following data is part of a premarket notification filed by Gambro-hosp-cobe, Inc. with the FDA for Hospal Bicart Retrofit Kit Na/monit S Gs Hemodial.
| Device ID | K904967 |
| 510k Number | K904967 |
| Device Name: | HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL |
| Classification | System, Dialysate Delivery, Single Patient |
| Applicant | GAMBRO-HOSP-COBE, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Jeffrey Shideman |
| Correspondent | Jeffrey Shideman GAMBRO-HOSP-COBE, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Product Code | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-05 |
| Decision Date | 1991-01-28 |