21 C.F.R. § 880.5475

Current through October 31, 2024
Section 880.5475 - Jet lavage
(a)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.
(b)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 .

21 C.F.R. §880.5475

45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998