The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Incudostapedial Joint.
| Device ID | K925443 |
| 510k Number | K925443 |
| Device Name: | INCUDOSTAPEDIAL JOINT |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Jeff Cobb |
| Correspondent | Jeff Cobb SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-28 |
| Decision Date | 1993-03-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925024137 | K925443 | 000 |
| 00821925017375 | K925443 | 000 |
| 00821925017368 | K925443 | 000 |