The following data is part of a premarket notification filed by Denrick Corp. with the FDA for Denrick Speech Aid (dr-1).
| Device ID | K931371 |
| 510k Number | K931371 |
| Device Name: | DENRICK SPEECH AID (DR-1) |
| Classification | Larynx, Artificial (battery-powered) |
| Applicant | DENRICK CORP. 469 ENA RD., SUITE 3003 Honolulu, HI 96815 |
| Contact | Dennis Kosanke |
| Correspondent | Dennis Kosanke DENRICK CORP. 469 ENA RD., SUITE 3003 Honolulu, HI 96815 |
| Product Code | ESE |
| CFR Regulation Number | 874.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-17 |
| Decision Date | 1993-08-25 |