Teething ring.

21 C.F.R. § 872.5550
in effectEffective: 2024-07-01
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(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.

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