§878.3590. Ear prosthesis.
21 C.F.R. § 878.3590
Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.
Classification. Class II.
Notes, amendments, and revision history
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.