The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Septal Button.
| Device ID | K781529 |
| 510k Number | K781529 |
| Device Name: | SEPTAL BUTTON |
| Classification | Button, Nasal Septal |
| Applicant | XOMED, INC. 1318 LONEDELL RD. Arnold, MO 63010 |
| Product Code | LFB |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-05 |
| Decision Date | 1978-10-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681490195348 | K781529 | 000 |
| 00763000886738 | K781529 | 000 |
| 00763000035686 | K781529 | 000 |
| 00763000035693 | K781529 | 000 |
| 00763000036119 | K781529 | 000 |
| 00681490041935 | K781529 | 000 |
| 00681490041942 | K781529 | 000 |
| 00681490195317 | K781529 | 000 |
| 00681490195331 | K781529 | 000 |
| 00763000886721 | K781529 | 000 |