← Product Code [HHE](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE) · K870803

# THE KEEPER (K870803)

_The Keeper Co. · HHE · May 6, 1987 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K870803

## Device Facts

- **Applicant:** The Keeper Co.
- **Product Code:** [HHE](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE.md)
- **Decision Date:** May 6, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.5400
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

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

## Special Controls

*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.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K870803](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K870803)

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