Title 21: Food and Drugs
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/ PART 878 - GENERAL AND PLASTIC SURGERY DEVICES
/ Subpart E - Surgical Devices / § 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.