The following data is part of a premarket notification filed by Hi-tech Laboratories, Inc. with the FDA for Hi-tech Lab Model Concha All In Ear.
| Device ID | K853967 |
| 510k Number | K853967 |
| Device Name: | HI-TECH LAB MODEL CONCHA ALL IN EAR |
| Classification | Hearing Aid, Air Conduction |
| Applicant | HI-TECH LABORATORIES, INC. P.O. BOX 1330 1008 A STREET Blue Springs, MO 64015 |
| Contact | Howard E Sander |
| Correspondent | Howard E Sander HI-TECH LABORATORIES, INC. P.O. BOX 1330 1008 A STREET Blue Springs, MO 64015 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-26 |
| Decision Date | 1985-12-27 |