COLONIC BALLOON DILATOR
Device Facts
| Record ID | K901426 |
|---|---|
| Device Name | COLONIC BALLOON DILATOR |
| Applicant | Telemed Systems, Inc. |
| Product Code | FFP · Gastroenterology, Urology |
| Decision Date | Jun 21, 1990 |
| 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.
