The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Air Conduction In-the-ear Hearing Aid Ua/115/scr.
| Device ID | K872645 |
| 510k Number | K872645 |
| Device Name: | AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR |
| Classification | Face Plate Hearing Aid |
| Applicant | RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Robert F Games |
| Correspondent | Robert F Games RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | LRB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-06 |
| Decision Date | 1987-12-08 |