The following data is part of a premarket notification filed by Preferred Medical Devices, Inc. with the FDA for Urassist.
| Device ID | K062061 |
| 510k Number | K062061 |
| Device Name: | URASSIST |
| Classification | Collector, Urine, Powered, Non Indwelling Catheter |
| Applicant | PREFERRED MEDICAL DEVICES, INC. 8 GRAY LODGE ROAD Kittery, ME 03904 |
| Contact | Penelope Greco |
| Correspondent | Penelope Greco PREFERRED MEDICAL DEVICES, INC. 8 GRAY LODGE ROAD Kittery, ME 03904 |
| Product Code | NZU |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-20 |
| Decision Date | 2006-10-05 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() URASSIST 76654997 3340587 Dead/Cancelled |
PREFERRED MEDICAL DEVICES, INC. 2006-02-13 |