The following data is part of a premarket notification filed by American V. Mueller with the FDA for Duckbill Voice Prosthesis & Tracheo.
| Device ID | K832967 |
| 510k Number | K832967 |
| Device Name: | DUCKBILL VOICE PROSTHESIS & TRACHEO |
| Classification | Prosthesis, Laryngeal (taub) |
| Applicant | AMERICAN V. MUELLER 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 | 1983-09-01 |
| Decision Date | 1983-12-23 |