Title 21

SECTION 872.5550

872.5550 Teething ring.

§ 872.5550 Teething ring.

(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]

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