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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 880 - General Hospital and Personal Use Devices |
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Subpart G - General Hospital and Personal Use Miscellaneous Devices |
§ 880.6150 - Ultrasonic cleaner for medical instruments.
Latest version.
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§ 880.6150 Ultrasonic cleaner for medical instruments.
(a) Identification. An ultrasonic cleaner for medical instruments is a device intended for cleaning medical instruments by the emission of high frequency soundwaves.
(b) Classification. Class I. The device, including any solutions intended for use with the device for cleaning and sanitizing the instruments, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 59 FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, 2001]