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53 FR 23872, June 24, 1988, unless otherwise noted.
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Nomenclature changes to part 878 appear at 73 FR 35341, June 23, 2008.
(a) Identification. A low energy ultrasound wound cleaner is a device that uses ultrasound energy to vaporize a solution and generate a mist that is used for the cleaning and maintenance debridement of wounds. Low levels of ultrasound energy may be carried to the wound by the saline mist.
(b) Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.” See § 878.1(e) for the availability of this guidance document.
[70 FR 67355, Nov. 7, 2005]