The following data is part of a premarket notification filed by Urethrotech with the FDA for Urethrotech Ucd.
| Device ID | K190060 |
| 510k Number | K190060 |
| Device Name: | Urethrotech UCD |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | Urethrotech 24 Garth Road Kingston Upon Thames, GB Kt2 5ny |
| Contact | Daniela Andrich |
| Correspondent | Yolanda Smith Smith Associates 1468 Harwell Ave. Crofton, MD 21114 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-11 |
| Decision Date | 2019-10-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() URETHROTECH UCD 79191702 5262969 Live/Registered |
Urethrotech Limited 2016-06-02 |