The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Blom-singer Voice Prosthesis.
| Device ID | K812982 |
| 510k Number | K812982 |
| Device Name: | BLOM-SINGER VOICE PROSTHESIS |
| Classification | Prosthesis, Laryngeal (taub) |
| Applicant | BIVONA MEDICAL TECHNOLOGIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EWL |
| CFR Regulation Number | 874.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-23 |
| Decision Date | 1981-11-24 |