[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874.4780]

[Page 342]
 
                        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. 874.4780  Intranasal splint.

    (a) 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.
    (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]

[[Page 343]]