Code of Federal Regulations · Section
§ 886.4370 — Keratome
21 C.F.R. § 886.4370
View:
(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.
Authorizing Statute
-
Adulterated drugs and devices21 U.S.C. § 351