PASSAGE AIRWAY SPLINT
Device Facts
| Record ID | K901307 |
|---|---|
| Device Name | PASSAGE AIRWAY SPLINT |
| Applicant | Invotec International, Inc. |
| Product Code | LYA · Ear, Nose, Throat |
| Decision Date | Jun 14, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4780 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.
