1. Regulations
  2. title 21
  3. chapter I-i7
  4. part 878
  5. subpart D
  6. § 878.3590

View all text of Subpart D [§ 878.3250 - § 878.3925]

§ 878.3590 - Ear prosthesis.

(a) Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.

(b) Classification. Class II.

AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

SOURCE: 53 FR 23872, June 24, 1988, unless otherwise noted.

CITE AS: 21 CFR 878.3590