The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Dialysis Control Unit-centry 2000.
| Device ID | K802250 |
| 510k Number | K802250 |
| Device Name: | DIALYSIS CONTROL UNIT-CENTRY 2000 |
| Classification | System, Dialysate Delivery, Single Patient |
| Applicant | COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-16 |
| Decision Date | 1980-12-10 |