§ 886.4270. Intraocular gas.
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/us/cfr/t21/s§ 886.4270·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An intraocular gas is a device consisting of a gaseous fluid intended to be introduced into the eye to place pressure on a detached retina.
(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 § 886.3.