21 C.F.R. § 878.3750

Current through October 31, 2024
Section 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 (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 .

21 C.F.R. §878.3750

53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38802 , July 25, 2001