The following data is part of a premarket notification filed by Invotec International, Inc. with the FDA for Passage Airway Splint.
| Device ID | K901307 |
| 510k Number | K901307 |
| Device Name: | PASSAGE AIRWAY SPLINT |
| Classification | Splint, Intranasal 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 | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-20 |
| Decision Date | 1990-06-14 |