The following data is part of a premarket notification filed by Finetone Hearing Instruments with the FDA for Finetone Disceet Canal.
| Device ID | K945780 |
| 510k Number | K945780 |
| Device Name: | FINETONE DISCEET CANAL |
| Classification | Hearing Aid, Air Conduction |
| Applicant | FINETONE HEARING INSTRUMENTS 301 U.S. RT. 1 Scarborough, ME 04074 |
| Contact | Jeffrey A Mclaughlin |
| Correspondent | Jeffrey A Mclaughlin FINETONE HEARING INSTRUMENTS 301 U.S. RT. 1 Scarborough, ME 04074 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-25 |
| Decision Date | 1994-12-21 |