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e-CFR data is current as of January 19, 2021 |
Title 21 → Chapter I → Subchapter H → Part 882 → Subpart E → §882.4305 |
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart E—Neurological Surgical Devices
§882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.
(a) Identification. Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain.
(b) Classification. Class II (performance standards).