The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Micromedics Nasal Septal Button.
| Device ID | K982667 |
| 510k Number | K982667 |
| Device Name: | MICROMEDICS NASAL SEPTAL BUTTON |
| Classification | Button, Nasal Septal |
| Applicant | MICROMEDICS, INC. 1285 CORPORATE CENTER DR., #150 Eagan, MN 55121 |
| Contact | Charles Grote |
| Correspondent | Charles Grote MICROMEDICS, INC. 1285 CORPORATE CENTER DR., #150 Eagan, MN 55121 |
| 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 | 1998-07-31 |
| Decision Date | 1998-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00385640000024 | K982667 | 000 |
| 00385640000017 | K982667 | 000 |
| 00385640000000 | K982667 | 000 |
| 10385640065228 | K982667 | 000 |
| 10385640065211 | K982667 | 000 |
| 10385640065204 | K982667 | 000 |