21 CFR 868.5760
§ 868.5760 Cuff spreader.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 868.5760, § 868.5760 Cuff spreader, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89831
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Full text
(a) Identification. A cuff spreader is a device used to install tracheal tube cuffs on tracheal or tracheostomy tubes.
(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 § 868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.