Manual cranial drills, burrs, trephines, and their accessories

21 C.F.R. § 882.4300
in effectEffective: 2024-07-01
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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).

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