§878.4680. Nonpowered, single patient, portable suction apparatus.
21 C.F.R. § 878.4680
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.
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.
Notes, amendments, and revision history
Amendments
[53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 53 FR 23872, June 24, 1988, unless otherwise noted.
Amendments
[53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000]