← Product Code [HGY](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGY) · K840325

# INFA COMPLETE BREAST PUMP & MILK STORAG (K840325)

_Monterey Laboratories, Inc. · HGY · Mar 5, 1984 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGY/K840325

## Device Facts

- **Applicant:** Monterey Laboratories, Inc.
- **Product Code:** [HGY](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGY.md)
- **Decision Date:** Mar 5, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.5150
- **Device Class:** Class 1
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

A nonpowered breast pump is a manual suction device used to express milk from the breast.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGY/K840325](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGY/K840325)

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