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21 CFR 874.4800

§ 874.4800 Bone particle collector.

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

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21 CFR 874.4800, § 874.4800 Bone particle collector, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90251
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(a) Identification. A bone particle collector is a filtering device intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use. (b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.