The following data is part of a premarket notification filed by Lori Medical Laboratories, Inc. with the FDA for Loripro, Loripro Ii.
| Device ID | K972058 |
| 510k Number | K972058 |
| Device Name: | LORIPRO, LORIPRO II |
| Classification | Hearing Aid, Air Conduction |
| Applicant | LORI MEDICAL LABORATORIES, INC. 696 MENDELSSOHN AVE. NORTH Golden Valley, MN 55427 -4306 |
| Contact | Gary Maas |
| Correspondent | Gary Maas LORI MEDICAL LABORATORIES, INC. 696 MENDELSSOHN AVE. NORTH Golden Valley, MN 55427 -4306 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-02 |
| Decision Date | 1997-08-15 |