MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT
Device Facts
| Record ID | K935658 |
|---|---|
| Device Name | MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT |
| Applicant | Merocel Corp. |
| Product Code | LYA · Ear, Nose, Throat |
| Decision Date | Mar 4, 1994 |
| 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.
