The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Wehrs Incus And Incus-stapes Prostheses.
| Device ID | K910685 |
| 510k Number | K910685 |
| Device Name: | WEHRS INCUS AND INCUS-STAPES PROSTHESES |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Robert F Games |
| Correspondent | Robert F Games SMITH & NEPHEW RICHARDS, 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 | 1991-02-19 |
| Decision Date | 1991-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925024595 | K910685 | 000 |
| 00821925014923 | K910685 | 000 |
| 00821925014930 | K910685 | 000 |
| 00821925014947 | K910685 | 000 |
| 00821925014954 | K910685 | 000 |
| 00821925015586 | K910685 | 000 |
| 00821925015777 | K910685 | 000 |
| 00821925017351 | K910685 | 000 |
| 00821925020276 | K910685 | 000 |
| 00821925020283 | K910685 | 000 |
| 00821925020290 | K910685 | 000 |
| 00821925020306 | K910685 | 000 |
| 00821925020313 | K910685 | 000 |
| 00821925020320 | K910685 | 000 |
| 00821925020337 | K910685 | 000 |
| 00821925014381 | K910685 | 000 |