The following data is part of a premarket notification filed by Finetone Hearing Instruments with the FDA for Super-sil.
| Device ID | K940164 |
| 510k Number | K940164 |
| Device Name: | SUPER-SIL |
| Classification | Hearing Aid, Air Conduction |
| Applicant | FINETONE HEARING INSTRUMENTS 200 JOHN ROBERTS RD. South Portland, ME 04106 |
| Contact | Jeffrey A Mclaughlin |
| Correspondent | Jeffrey A Mclaughlin FINETONE HEARING INSTRUMENTS 200 JOHN ROBERTS RD. South Portland, ME 04106 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-06 |
| Decision Date | 1994-06-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SUPER-SIL 74466626 1991582 Dead/Cancelled |
National Hearing Aid Distributors, Inc. 1993-12-03 |