Title 21: Food and Drugs
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/ PART 882 - NEUROLOGICAL DEVICES
/ Subpart E - Neurological Surgical Devices / § 882.4300 Manual cranial drills, burrs, trephines, and their accessories
§ 882.4300 Manual cranial drills, burrs, trephines, and their accessories
(a) Identification. Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.
(b) Classification. Class II (performance standards).