§880.5475. Jet lavage.
21 C.F.R. § 880.5475
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Notes, amendments, and revision history
Amendments
[45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.
Amendments
[45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]