21 CFR 882.4030
§ 882.4030 Skull plate anvil.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 882.4030, § 882.4030 Skull plate anvil, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90677
- Permanent ID
ys:prov:90677@1- SHA-256
112e35d42705c22d1afa30eddf40e3d71424ae3a839573504091ceedd8dd961c
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identification. A skull plate anvil is a device used to form alterable skull plates in the proper shape to fit the curvature of a patient's skull.
(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 the limitations in § 882.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.