21 C.F.R. · Food and Drugs
21 C.F.R. § 874.3495

Total ossicular replacement prosthesis.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 874.3495 — Total ossicular replacement prosthesis.

§ 874.3495 Total ossicular replacement prosthesis. (a) Identification. A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials. (b) Classification. Class II.

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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21 C.F.R. § 874.3495
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The regulatory text of 21 C.F.R. § 874.3495 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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boisestandard.org United States Law CFR Title 21 21 C.F.R. § 874.3495