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 |