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§882.4310. Powered simple cranial drills, burrs, trephines, and their accessories.

21 C.F.R. § 882.4310

(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).
Notes, amendments, and revision history

Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

Source

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.