§886.4370. Keratome.
21 C.F.R. § 886.4370
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.
Classification. Class I.
Notes, amendments, and revision history
Amendments
[55 FR 48443, Nov. 20, 1990]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.
Amendments
[55 FR 48443, Nov. 20, 1990]