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e-CFR data is current as of July 1, 2020

Title 21Chapter ISubchapter HPart 880Subpart G → §880.6150


Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart G—General Hospital and Personal Use Miscellaneous Devices


§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]

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