The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace Disp. Lines For Physio. Press.
| Device ID | K801322 |
| 510k Number | K801322 |
| Device Name: | MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | GRAPHIC CONTROLS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-05 |
| Decision Date | 1980-06-30 |