The following data is part of a premarket notification filed by Lori Medical Laboratories, Inc. with the FDA for Lori-a.
| Device ID | K952711 |
| 510k Number | K952711 |
| Device Name: | LORI-A |
| Classification | Hearing Aid, Air Conduction |
| Applicant | LORI MEDICAL LABORATORIES, INC. 830 BOONE AVE. Golden Valley, MN 55327 |
| Contact | Gary R Maas |
| Correspondent | Gary R Maas LORI MEDICAL LABORATORIES, INC. 830 BOONE AVE. Golden Valley, MN 55327 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-14 |
| Decision Date | 1995-07-03 |