The following data is part of a premarket notification filed by Advanced Bioresearch Assoc. with the FDA for Dristar Urinary Incontinence Management System.
| Device ID | K950784 |
| 510k Number | K950784 |
| Device Name: | DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM |
| Classification | Garment, Protective, For Incontinence |
| Applicant | ADVANCED BIORESEARCH ASSOC. 1700 ROCKVILLE PIKE, SUITE 450 Rockville, MD 20852 |
| Contact | Steve Reitzler |
| Correspondent | Steve Reitzler ADVANCED BIORESEARCH ASSOC. 1700 ROCKVILLE PIKE, SUITE 450 Rockville, MD 20852 |
| Product Code | EYQ |
| CFR Regulation Number | 876.5920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-21 |
| Decision Date | 1995-05-03 |