21 C.F.R. § 878.4680 Nonpowered, single patient, portable suction apparatus.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart E—Surgical Devices
§ 878.4680 Nonpowered, single patient, portable suction apparatus.
