The following data is part of a premarket notification filed by C.g.h. Medical, Inc. with the FDA for Gambro Bicart 720g.
| Device ID | K940601 |
| 510k Number | K940601 |
| Device Name: | GAMBRO BICART 720G |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | C.G.H. MEDICAL, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman C.G.H. MEDICAL, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-10 |
| Decision Date | 1994-03-22 |