The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Black Oval-top Torp/porp.
| Device ID | K934107 |
| 510k Number | K934107 |
| Device Name: | BLACK OVAL-TOP TORP/PORP |
| Classification | Replacement, Ossicular Prosthesis, Total |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Ronald K Smith |
| Correspondent | Ronald K Smith SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | ETA |
| CFR Regulation Number | 874.3495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-23 |
| Decision Date | 1994-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925023963 | K934107 | 000 |
| 00821925023956 | K934107 | 000 |
| 00821925012271 | K934107 | 000 |
| 00821925012264 | K934107 | 000 |