Code of Federal Regulations · Section
§ 882.4300 — Manual Cranial Drills, Burrs, Trephines, And Their Accessories
21 C.F.R. § 882.4300
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(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).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351