Electronic Code of Federal Regulations
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e-CFR data is current as of February 23, 2021 |
Title 21 → Chapter I → Subchapter H → Part 882 → Subpart E → §882.4750 |
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart E—Neurological Surgical Devices
§882.4750 Skull punch.
(a) 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.
(b) 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.
[44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000]