Submission Details
| 510(k) Number | K982667 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 31, 1998 |
| Decision Date | November 24, 1998 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
K982667 is an FDA 510(k) clearance for the MICROMEDICS NASAL SEPTAL BUTTON, a Button, Nasal Septal, submitted by Micromedics, Inc. (Eagan, US). The FDA issued a Cleared decision on November 24, 1998, 116 days after receiving the submission on July 31, 1998. This device falls under the Ear, Nose, Throat review panel.
| 510(k) Number | K982667 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 31, 1998 |
| Decision Date | November 24, 1998 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | LFB — Button, Nasal Septal |
| Device Class | — |