Submission Details
| 510(k) Number | K013696 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 07, 2001 |
| Decision Date | November 28, 2001 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
K013696 is an FDA 510(k) clearance for the SILMED NASAL SEPTAL BUTTON, a Button, Nasal Septal, submitted by Silmed, Inc. (Leesburg,, US). The FDA issued a Cleared decision on November 28, 2001, 21 days after receiving the submission on November 7, 2001. This device falls under the Ear, Nose, Throat review panel.
| 510(k) Number | K013696 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 07, 2001 |
| Decision Date | November 28, 2001 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | LFB — Button, Nasal Septal |
| Device Class | — |