PRO-FLO SYSTEM
Device Facts
| Record ID | K931896 |
|---|---|
| Device Name | PRO-FLO SYSTEM |
| Applicant | Lafayette Pharmacal, Inc. |
| Product Code | FCE · Gastroenterology, Urology |
| Decision Date | Aug 26, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5210 |
| Device Class | Class 1 |
Regulatory Classification
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).
