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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 878 - General and Plastic Surgery Devices |
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Subpart D - Prosthetic Devices |
§ 878.3590 - Ear prosthesis.
Latest version.
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§ 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.