[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: 21CFR878.3500]

[Page 370]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 878--GENERAL AND PLASTIC SURGERY DEVICES--Table of Contents
 
                      Subpart D--Prosthetic Devices
 
Sec. 878.3500  Polytetrafluoroethylene with carbon fibers composite implant material.

    (a) Identification. A polytetrafluoroethylene with carbon fibers 
composite implant material is a porous device material intended to be 
implanted during surgery of the chin, jaw, nose, or bones or tissue near 
the eye or ear. The device material serves as a space-occupying 
substance and is shaped and formed by the surgeon to conform to the 
patient's need.
    (b) Classification. Class II.