U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
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All TitlesTitle 21Chapter IPart 880Subpart G - Subpart G—General Hospital and Personal Use Miscellaneous Devices
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(a) Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.
(b) Classification. Class II (performance standards).