The following data is part of a premarket notification filed by Medefield Pty. Ltd. with the FDA for Medefoam-2.
| Device ID | K800840 |
| 510k Number | K800840 |
| Device Name: | MEDEFOAM-2 |
| Classification | Medium, Contrast, Radiologic |
| Applicant | MEDEFIELD PTY. LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KTA |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-15 |
| Decision Date | 1980-06-17 |