§882.4750. Skull punch.
21 C.F.R. § 882.4750
Identification. A skull punch is a device used to punch holes through a patient's skull to allow fixation of cranioplasty plates or bone flaps by wire or other means.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. This exemption does not apply to powered compound cranial drills, burrs, trephines, and their accessories classified under § 882.4305.
Notes, amendments, and revision history
Amendments
[44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000]
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.
Amendments
[44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000]