The following data is part of a premarket notification filed by American V. Mueller with the FDA for Blom-singer Low Pressure Voice Prosthes.
| Device ID | K842896 |
| 510k Number | K842896 |
| Device Name: | BLOM-SINGER LOW PRESSURE VOICE PROSTHES |
| Classification | Prosthesis, Laryngeal (taub) |
| Applicant | AMERICAN V. MUELLER 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EWL |
| CFR Regulation Number | 874.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-23 |
| Decision Date | 1984-08-17 |