21 C.F.R. § 886.4370 Keratome.
Title 21 - Food and Drugs
(a) Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant. (b) Classification. Class I. [55 FR 48443, Nov. 20, 1990]
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart E—Surgical Devices
§ 886.4370 Keratome.
