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 |