The following data is part of a premarket notification filed by Midwest City Hearing Aid Center with the FDA for Custom Canal & Full Concha Instr (class D Cir Opt).
| Device ID | K953037 |
| 510k Number | K953037 |
| Device Name: | CUSTOM CANAL & FULL CONCHA INSTR (CLASS D CIR OPT) |
| Classification | Hearing Aid, Air Conduction |
| Applicant | MIDWEST CITY HEARING AID CENTER 1401 SOUTH MIDWEST BLVD. Midwest City, OK 73110 |
| Contact | Frank Carter |
| Correspondent | Frank Carter MIDWEST CITY HEARING AID CENTER 1401 SOUTH MIDWEST BLVD. Midwest City, OK 73110 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-19 |
| Decision Date | 1995-07-20 |