Title 21

SECTION 878.4680

878.4680 Nonpowered, single patient, portable suction apparatus.

§ 878.4680 Nonpowered, single patient, portable suction apparatus.

(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]

---