The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Hasson Buec-3.
| Device ID | K820672 |
| 510k Number | K820672 |
| Device Name: | HASSON BUEC-3 |
| Classification | Elevator, Uterine |
| Applicant | BIVONA MEDICAL TECHNOLOGIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HDP |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-11 |
| Decision Date | 1982-07-30 |