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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 E - Surgical Devices |
§ 878.4520 - Polytetrafluoroethylene injectable.
Latest version.
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§ 878.4520 Polytetrafluoroethylene injectable.
(a) Identification. Polytetrafluoroethylene injectable is an injectable paste prosthetic device composed of polytetrafluoroethylene intended to be used to augment or reconstruct a vocal cord.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3.