§ 878.4680. Nonpowered, single patient, portable suction apparatus.
76 words·~1 min read·
/us/cfr/t21/s§ 878.4680·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.
(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 § 878.9. [53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000]