Section 882.4600 - Leukotome(a)Identification. A leukotome is a device used to cut sections out of the brain.(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 § 882.9 .44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808 , July 25, 2001