Code of Federal Regulations · Section

§ 884.5400 — Menstrual Cup

21 C.F.R. § 884.5400

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(a) Identification. A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

21 C.F.R. § 884.5390 21 C.F.R. § 884.5425

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