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Title 21 Part 886 → Subpart E → §886.4355

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart E → §886.4355

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart E → §886.4355

e-CFR data is current as of September 12, 2019

Title 21Chapter ISubchapter HPart 886Subpart E → §886.4355


Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart E—Surgical Devices


§886.4355   Corneal inlay inserter handle.

(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.CITA>[84 FR 14870, Apr. 12, 2019]