The following data is part of a premarket notification filed by Finetone Hearing Instruments with the FDA for Faceplate Assembly.
| Device ID | K974219 |
| 510k Number | K974219 |
| Device Name: | FACEPLATE ASSEMBLY |
| Classification | Face Plate Hearing Aid |
| Applicant | FINETONE HEARING INSTRUMENTS 301 U.S. RT. 1 Scarborough, ME 04074 |
| Contact | Paul Menezes |
| Correspondent | Paul Menezes FINETONE HEARING INSTRUMENTS 301 U.S. RT. 1 Scarborough, ME 04074 |
| Product Code | LRB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-10 |
| Decision Date | 1998-02-20 |