- (a) Identification. A medical washer is a device that is intended for general medical purposes to clean and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.
- (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
[67 FR 69121, Nov. 15, 2002]