The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Incus Prosthesis.
| Device ID | K844961 |
| 510k Number | K844961 |
| Device Name: | INCUS PROSTHESIS |
| Classification | Prosthesis, Partial Ossicular Replacement |
| 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 | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-21 |
| Decision Date | 1985-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925040960 | K844961 | 000 |
| 00821925014732 | K844961 | 000 |
| 00821925015524 | K844961 | 000 |
| 00821925017689 | K844961 | 000 |
| 00821925017696 | K844961 | 000 |
| 00821925017702 | K844961 | 000 |
| 00821925017719 | K844961 | 000 |
| 00821925017726 | K844961 | 000 |
| 00821925017900 | K844961 | 000 |
| 00821925017917 | K844961 | 000 |
| 00821925012219 | K844961 | 000 |