The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Blom-singer Duckbill Voice Prosthesis.
| Device ID | K800563 |
| 510k Number | K800563 |
| Device Name: | BLOM-SINGER DUCKBILL 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 | 1980-03-13 |
| Decision Date | 1980-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813307010227 | K800563 | 000 |
| 00813307010210 | K800563 | 000 |
| 00813307010203 | K800563 | 000 |
| 00813307010197 | K800563 | 000 |
| 00813307010180 | K800563 | 000 |
| 00813307010173 | K800563 | 000 |