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52 FR 33355, Sept. 2, 1987, unless otherwise noted.
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Subscribe to: 21 CFR 886.3400
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Nomenclature changes to part 886 appear at 73 FR 35341, June 23, 2008.
(a) Identification. A keratoprosthesis is a device intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye that is not a reasonable candidate for a corneal transplant.
(b) Classification. Class II. The special controls for this device are FDA's:
(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and
(3) “Guidance on 510(k) Submissions for Keratoprostheses.”
[65 FR 17147, Mar. 31, 2000]