21 CFR 888.4200

§ 888.4200 Cement dispenser.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 888.4200, § 888.4200 Cement dispenser, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91135
Permanent ID: ys:prov:91135@1
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Full text

(a) Identification. A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (§ 888.3027) into surgical sites. (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.