The following data is part of a premarket notification filed by Gics Pharmaceuticals with the FDA for Cps-1000.
| Device ID | K802890 |
| 510k Number | K802890 |
| Device Name: | CPS-1000 |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | GICS PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-17 |
| Decision Date | 1981-03-05 |