[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874.3620]

[Page 368]
 
                        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. 874.3620  Ear, nose, and throat synthetic polymer material.

    (a) Identification. Ear, nose, and throat synthetic polymer material 
is a device material that is intended to be implanted for use as a 
space-occupying substance in the reconstructive surgery of the head and 
neck. The device is used, for example, in augmentation rhinoplasty and 
in tissue defect closures in the esophagus. The device is shaped and 
formed by the suregon to conform to the patient's needs. This generic 
type of device is made of material such as polyamide mesh or foil and 
porous polyethylene.
    (b) Classification. Class II.