Title 21: Food and Drugs
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/ PART 882 - NEUROLOGICAL DEVICES
/ Subpart E - Neurological Surgical Devices / § 882.4600 Leukotome.
§ 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.