The following data is part of a premarket notification filed by E. Benson Hood Lab, Inc. with the FDA for Voice Master Prosthesis.
| Device ID | K974132 |
| 510k Number | K974132 |
| Device Name: | VOICE MASTER PROSTHESIS |
| Classification | Prosthesis, Laryngeal (taub) |
| Applicant | E. BENSON HOOD LAB, INC. 575 WASHINGTON ST. Pembroke, MA 02359 |
| Contact | Anthony M Sacchetti |
| Correspondent | Anthony M Sacchetti E. BENSON HOOD LAB, INC. 575 WASHINGTON ST. Pembroke, MA 02359 |
| Product Code | EWL |
| CFR Regulation Number | 874.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-03 |
| Decision Date | 1998-02-25 |
| Summary: | summary |