INAMED RHEMO-D (TM) DILATOR
Device Facts
| Record ID | K894618 |
|---|---|
| Device Name | INAMED RHEMO-D (TM) DILATOR |
| Applicant | Inamed Development Co. |
| Product Code | FFP · Gastroenterology, Urology |
| Decision Date | Jan 18, 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.
