[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874.3900]

[Page 344-345]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 874--EAR, NOSE, AND THROAT DEVICES--Table of Contents
 
                      Subpart D--Prosthetic Devices
 
Sec. 874.3900  Nasal dilator.

    (a) 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

[[Page 345]]

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.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 874.9.

[64 FR 10949, Mar. 8, 1999]