The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Incus/stapes Prosthesis.
| Device ID | K861369 |
| 510k Number | K861369 |
| Device Name: | INCUS/STAPES PROSTHESIS |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Roberts F Games |
| Correspondent | Roberts F Games RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-11 |
| Decision Date | 1986-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925025042 | K861369 | 000 |
| 00821925024199 | K861369 | 000 |
| 00821925023307 | K861369 | 000 |
| 00821925017894 | K861369 | 000 |
| 00821925017887 | K861369 | 000 |
| 00821925017870 | K861369 | 000 |
| 00821925015562 | K861369 | 000 |
| 00821925014305 | K861369 | 000 |