[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: 21CFR874.4100]

[Page 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 E--Surgical Devices
 
Sec. 874.4100  Epistaxis balloon.


    (a) Identification. An epistaxis balloon is a device consisting of 
an inflatable balloon intended to control internal nasal bleeding by 
exerting pressure against the sphenopalatine artery.
    (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 Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000]