The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Fome-cuf Pvc.
| Device ID | K780583 |
| 510k Number | K780583 |
| Device Name: | FOME-CUF PVC |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | BIVONA MEDICAL TECHNOLOGIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-12 |
| Decision Date | 1978-05-12 |