The following data is part of a premarket notification filed by Bruce Medical Supply with the FDA for Lectro-larynx.
| Device ID | K923648 |
| 510k Number | K923648 |
| Device Name: | LECTRO-LARYNX |
| Classification | Larynx, Artificial (battery-powered) |
| Applicant | BRUCE MEDICAL SUPPLY 411 WAVERLY OAKS RD. Waltham, MA 02154 |
| Contact | Richard A Najarian |
| Correspondent | Richard A Najarian BRUCE MEDICAL SUPPLY 411 WAVERLY OAKS RD. Waltham, MA 02154 |
| Product Code | ESE |
| CFR Regulation Number | 874.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-21 |
| Decision Date | 1993-04-07 |