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47 FR 31142, July 16, 1982, unless otherwise noted.
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Nomenclature changes to part 868 appear at 73 FR 35341, June 23, 2008.
(a) Identification. The device is a raised, rounded pad that, in the event of choking on a foreign body, can be applied to the abdomen and pushed upward to generate expulsion pressure to remove the obstruction to relieve acute upper airway obstruction.
(b) Classification. Class II (special controls) (“Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices”). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to § 868.9.
[65 FR 39099, June 23, 2000; 65 FR 47669, Aug. 3, 2000]