[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.5475]

[Page 390]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES--Table of Contents
 
    Subpart F--General Hospital and Personal Use Therapeutic Devices
 
Sec. 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 Sec. 880.9.

[45 FR 69682-69737, Oct. 21, l980, as amended at 63 FR 59229, Nov. 3, 
1998]