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21 CFR 882.4650

§ 882.4650 Neurosurgical suture needle.

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

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21 CFR 882.4650, § 882.4650 Neurosurgical suture needle, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90704
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(a) Identification. A neurosurgical suture needle is a needle used in suturing during neurosurgical procedures or in the repair of nervous tissue. (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 § 882.9.

Legislative history

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