The following data is part of a premarket notification filed by Silmed, Inc. with the FDA for Silmed Nasal Septal Button.
| Device ID | K013696 |
| 510k Number | K013696 |
| Device Name: | SILMED NASAL SEPTAL BUTTON |
| Classification | Button, Nasal Septal |
| Applicant | SILMED, INC. 3987 LAKEVIEW TRAIL Leesburg,, IN 46538 |
| Contact | Rama Gundlapalli |
| Correspondent | Rama Gundlapalli SILMED, INC. 3987 LAKEVIEW TRAIL Leesburg,, IN 46538 |
| 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 | 2001-11-07 |
| Decision Date | 2001-11-28 |
| Summary: | summary |