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21 CFR 880.5475

§ 880.5475 Jet lavage.

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

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21 CFR 880.5475, § 880.5475 Jet lavage, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90541
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(a) Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Legislative history

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