[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: 21CFR878.3900]

[Page 366]
 
                        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. 878.3900  Inflatable extremity splint.

    (a) Identification. An inflatable extremity splint is a device 
intended to be inflated to immobilize a limb or an extremity.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994]