21 CFR 888.4230
§ 888.4230 Cement ventilation tube.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 888.4230, § 888.4230 Cement ventilation tube, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91138
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Full text
(a) Identification. A cement ventilation tube is a tube-like device usually made of plastic intended to be inserted into a surgical cavity to allow the release of air or fluid from the cavity as it is being filled with bone cement (§ 888.3027).
(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 § 888.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.