[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: 21CFR878.3750]

[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. 878.3750  External prosthesis adhesive.

    (a) Identification. An external prosthesis adhesive is a silicone-
type adhesive intended to be used to fasten to the body an external 
aesthetic restoration prosthesis, such as an artificial nose.
    (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]