← Product Code [FCD](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FCD) · K934585

# PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL (K934585)

_Lafayette Pharmaceuticals, Inc. · FCD · Nov 3, 1993 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/FCD/K934585

## Device Facts

- **Applicant:** Lafayette Pharmaceuticals, Inc.
- **Product Code:** [FCD](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FCD.md)
- **Decision Date:** Nov 3, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5210
- **Device Class:** Class 1
- **Review Panel:** Gastroenterology, Urology

## Regulatory Identification

An enema kit is a device intended to instill water or other fluids into the colon through a nozzle inserted into the rectum to promote evacuation of the contents of the lower colon. The device consists of a container for fluid connected to the nozzle either directly or via tubing. This device does not include the colonic irrigation system (§ 876.5220).

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/FCD/K934585](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/FCD/K934585)

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