Code of Federal Regulations · Section
§ 878.3590 — Ear Prosthesis
21 C.F.R. § 878.3590
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(a) Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.
(b) Classification. Class II.
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351