CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 878—GENERAL AND PLASTIC SURGERY DEVICES > SUBPART E—Surgical Devices (§878.4010 to §878.5040) > 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.

Code of Federal Regulations

[53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000]