[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: 21CFR878.3250]

[Page 395]
 
                        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. 878.3250  External facial fracture fixation appliance.


    (a) Identification. An external facial fracture fixation appliance 
is a metal apparatus intended to be used during surgical reconstruction 
and repair to immobilize maxillofacial bone fragments in their proper 
facial relationship.
    (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. 878.9.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 
FR 2317, Jan. 14, 2000]