The following data is part of a premarket notification filed by Lori Medical Laboratories, Inc. with the FDA for Lori Hearing Aid Simulator.
| Device ID | K964080 |
| 510k Number | K964080 |
| Device Name: | LORI HEARING AID SIMULATOR |
| Classification | Hearing Aid, Master |
| Applicant | LORI MEDICAL LABORATORIES, INC. 696 MENDELSSOHN AVE. NORTH Golden Valley, MN 55427 -4306 |
| Contact | Gary R Maas |
| Correspondent | Gary R Maas LORI MEDICAL LABORATORIES, INC. 696 MENDELSSOHN AVE. NORTH Golden Valley, MN 55427 -4306 |
| Product Code | KHL |
| CFR Regulation Number | 874.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-11 |
| Decision Date | 1997-01-08 |