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Code of Federal Regulations (Last Updated: July 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 |
§ 878.3500 - Polytetrafluoroethylene with carbon fibers composite implant material.
Latest version.
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§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(a) Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.
(b) Classification. Class II.