The following data is part of a premarket notification filed by Invotec International, Inc. with the FDA for Invotec Septal Button.
| Device ID | K901366 |
| 510k Number | K901366 |
| Device Name: | INVOTEC SEPTAL BUTTON |
| Classification | Button, Nasal Septal |
| Applicant | INVOTEC INTERNATIONAL, INC. 11330-1ST. JOHN'S INDUSTRIAL PARKWAY Jacksonville, FL 32216 |
| Contact | Jeffrey L Aull |
| Correspondent | Jeffrey L Aull INVOTEC INTERNATIONAL, INC. 11330-1ST. JOHN'S INDUSTRIAL PARKWAY Jacksonville, FL 32216 |
| 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 | 1990-03-23 |
| Decision Date | 1990-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818501020010 | K901366 | 000 |
| 00818501020003 | K901366 | 000 |