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 |