The following data is part of a premarket notification filed by Lori Medical Laboratories, Inc. with the FDA for Lori/lori, Lori-s (lori Stock Aid).
| Device ID | K973376 |
| 510k Number | K973376 |
| Device Name: | LORI/LORI, LORI-S (LORI STOCK AID) |
| Classification | Hearing Aid, Air Conduction |
| Applicant | LORI MEDICAL LABORATORIES, INC. 696 MENDELSSOHN AVE. NORTH Golden Valley, MN 55427 -4306 |
| Contact | Jim Hammarstedt |
| Correspondent | Jim Hammarstedt 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 | 1997-09-08 |
| Decision Date | 1997-10-14 |