21 C.F.R. § 878.3590 – Ear prosthesis. | Midpage

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Code of Federal Regulations

§ 878.3590

21 C.F.R. § 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.