The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace Disp. Stopcocks/physio. Press.
| Device ID | K801828 |
| 510k Number | K801828 |
| Device Name: | MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | GRAPHIC CONTROLS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-31 |
| Decision Date | 1980-08-27 |