The following data is part of a premarket notification filed by Microtek Medical, Inc. with the FDA for Microtek Septal Button.
| Device ID | K862497 |
| 510k Number | K862497 |
| Device Name: | MICROTEK SEPTAL BUTTON |
| Classification | Button, Nasal Septal |
| Applicant | MICROTEK MEDICAL, INC. POST OFFICE BOX 2487 Columbus, MS 39704 |
| Contact | Frank Lockhart |
| Correspondent | Frank Lockhart MICROTEK MEDICAL, INC. POST OFFICE BOX 2487 Columbus, MS 39704 |
| 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 | 1986-07-01 |
| Decision Date | 1986-07-14 |