§ 872.5550. Teething ring.
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/us/cfr/t21/s§ 872.5550·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process. (b)(1) Classification. Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
(2)Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 84 FR 71812, Dec. 30, 2019]