DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM
Device Facts
| Record ID | K950784 |
|---|---|
| Device Name | DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM |
| Applicant | Advanced Bioresearch Assoc. |
| Product Code | EYQ · Gastroenterology, Urology |
| Decision Date | May 3, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5920 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A protective garment for incontinence is a device that consists of absorbent padding and a fluid barrier and that is intended to protect an incontinent patient's garment from the patient's excreta. This generic type of device does not include diapers for infants.
