21 CFR 888.4220
§ 888.4220 Cement monomer vapor evacuator.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 888.4220, § 888.4220 Cement monomer vapor evacuator, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91137
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Full text
(a) Identification. A cement monomer vapor evacuator is a device intended for use during surgery to contain or remove undesirable fumes, such as monomer vapor from 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.