K950784 is an FDA 510(k) clearance for the DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM. This device is classified as a Garment, Protective, For Incontinence (Class I - General Controls, product code EYQ).
Submitted by Advanced Bioresearch Assoc. (Rockville, US). The FDA issued a Cleared decision on May 3, 1995, 71 days after receiving the submission on February 21, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5920.
| 510(k) Number | K950784 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 1995 |
| Decision Date | May 03, 1995 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EYQ — Garment, Protective, For Incontinence |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5920 |