BREATHE RIGHT NASAL STRIP
Device Facts
| Record ID | K953772 |
|---|---|
| Device Name | BREATHE RIGHT NASAL STRIP |
| Applicant | Cns, Inc. |
| Product Code | LWF · Ear, Nose, Throat |
| Decision Date | Oct 20, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3900 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decreases airway resistance and increases nasal airflow. The external nasal dilator is constructed from one or more layers of material upon which a spring material is attached, with a skin adhesive applied to adhere to the skin of the nose; it acts with a pulling action to open the nares. The internal nasal dilator is constructed from metal or plastic and is placed inside the nostrils; it acts by pushing the nostrils open or by gently pressing on the columella.
