The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Bivona Ultra Low Resistance Voice Prosthesis.
| Device ID | K881011 |
| 510k Number | K881011 |
| Device Name: | BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS |
| Classification | Prosthesis, Laryngeal (taub) |
| Applicant | BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
| Contact | Shapiro, M.d. |
| Correspondent | Shapiro, M.d. BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
| Product Code | EWL |
| CFR Regulation Number | 874.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-10 |
| Decision Date | 1988-05-13 |