The following data is part of a premarket notification filed by Lee Electronics with the FDA for Lee Electronics Pal.
| Device ID | K854637 |
| 510k Number | K854637 |
| Device Name: | LEE ELECTRONICS PAL |
| Classification | Hearing Aid, Air Conduction |
| Applicant | LEE ELECTRONICS 983 N.W. SPRUCE ST. Corvallis, OR 97330 |
| Contact | Peter A Lee |
| Correspondent | Peter A Lee LEE ELECTRONICS 983 N.W. SPRUCE ST. Corvallis, OR 97330 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-19 |
| Decision Date | 1986-04-29 |