§878.3750. External prosthesis adhesive.
21 C.F.R. § 878.3750
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.
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 the limitations in § 878.9.
Notes, amendments, and revision history
Amendments
[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 53 FR 23872, June 24, 1988, unless otherwise noted.
Amendments
[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001]