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21 CFR 878.3590

§ 878.3590 Ear prosthesis.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 878.3590, § 878.3590 Ear prosthesis, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90393
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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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.