COLONIC BALLOON DIALATORS
Device Facts
| Record ID | K884713 |
|---|---|
| Device Name | COLONIC BALLOON DIALATORS |
| Applicant | Primrose Medical, Inc. |
| Product Code | FFP · Gastroenterology, Urology |
| Decision Date | Sep 29, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5450 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A rectal dilator is a device designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument.
