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Code · CFR · Title 21 — Food and Drugs · Part 878 — General and Plastic Surgery Devices · § 878.5080

§ 878.5080. Air-handling apparatus accessory.

94 words·~1 min read·/us/cfr/t21/s§ 878.5080·

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(a)Identification. An air-handling apparatus accessory is a supplementary device that is intended to be used with an air-handling apparatus for a surgical operating room. This device provides an interface between the components of the device or can be used to switch electrical power. This generic type of device includes fittings, adapters, couplers, remote switches, and footswitches.
(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 § 878.9. [84 FR 14870, Apr. 12, 2019]
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