Title 21: Food and Drugs
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/ PART 882 - NEUROLOGICAL DEVICES
/ Subpart E - Neurological Surgical Devices / § 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.
§ 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).