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21 C.F.R. § 882.4300   Manual cranial drills, burrs, trephines, and their accessories

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart E—Neurological Surgical Devices

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§ 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).

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