K974132 is an FDA 510(k) clearance for the VOICE MASTER PROSTHESIS. This device is classified as a Prosthesis, Laryngeal (taub) (Class II - Special Controls, product code EWL).
Submitted by E. Benson Hood Lab, Inc. (Pembroke, US). The FDA issued a Cleared decision on February 25, 1998, 114 days after receiving the submission on November 3, 1997.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3730.
| 510(k) Number | K974132 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 1997 |
| Decision Date | February 25, 1998 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EWL — Prosthesis, Laryngeal (taub) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3730 |