§ 886.4355. Corneal inlay inserter handle.
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/us/cfr/t21/s§ 886.4355·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. The corneal inlay inserter handle is a hand-held device intended to be used as an accessory to a corneal inlay inserter. The device extends the length of the inlay inserter to aid in delivering the inlay implant.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. [84 FR 14870, Apr. 12, 2019]