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52 FR 33355, Sept. 2, 1987, unless otherwise noted.
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Subscribe to: 21 CFR 886.4275
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Nomenclature changes to part 886 appear at 73 FR 35341, June 23, 2008.
(a) Identification. An intraocular fluid is a device consisting of a nongaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
(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.