The following data is part of a premarket notification filed by Dakota Laboratories, Inc. with the FDA for Di Custom In The Ear And In The Canal.
| Device ID | K920657 |
| 510k Number | K920657 |
| Device Name: | DI CUSTOM IN THE EAR AND IN THE CANAL |
| Classification | Hearing Aid, Air Conduction |
| Applicant | DAKOTA LABORATORIES, INC. P.O. BOX 8 Lake Andes, SD 57356 |
| Contact | Don Trummer |
| Correspondent | Don Trummer DAKOTA LABORATORIES, INC. P.O. BOX 8 Lake Andes, SD 57356 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-12 |
| Decision Date | 1992-03-31 |