§ 878.4520. Polytetrafluoroethylene injectable.
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/us/cfr/t21/s§ 878.4520·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.