The following data is part of a premarket notification filed by Lori Medical Laboratories, Inc. with the FDA for Lori-model O, Low Profile In-the Ear Instrument.
| Device ID | K893721 |
| 510k Number | K893721 |
| Device Name: | LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT |
| Classification | Hearing Aid, Air Conduction |
| Applicant | LORI MEDICAL LABORATORIES, INC. P.O. BOX 302 Long Lake, MN 55356 |
| Contact | Richard R Maas |
| Correspondent | Richard R Maas LORI MEDICAL LABORATORIES, INC. P.O. BOX 302 Long Lake, MN 55356 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-17 |
| Decision Date | 1989-09-08 |