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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 882 - Neurological Devices |
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Subpart E - Neurological Surgical Devices |
§ 882.4310 - Powered simple cranial drills, burrs, trephines, and their accessories.
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§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a) Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.
(b) Classification. Class II (performance standards).