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e-CFR data is current as of February 23, 2021

Title 21Chapter ISubchapter HPart 882Subpart E → §882.4310


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


§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).

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