Polytetrafluoroethylene with carbon fibers composite implant material.

21 C.F.R. § 878.3500
in effectEffective: 2024-07-01
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(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.

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