FDA 510(k) Applications Submitted by Troy Thome

FDA 510(k) Number Submission Date Device Name Applicant
K180070 01/09/2018 SpeediCath Flex Coude Pro Coloplast
K230165 01/20/2023 Luja CoudΘ (20118 Male CH8 - small packaging (Pocket size)), Luja CoudΘ (20111 Male CH10 - small packaging (Pocket size)), Luja CoudΘ (20112 Male CH12 - small packaging (Pocket size)), Luja CoudΘ (20114 Male CH14 - small packaging (Pocket size)), Luja Cou Coloplast
K142309 08/19/2014 GEM Flow COUPLER Device and System Synovis Life Technologies, Inc.
K132727 09/03/2013 GEM FLOW COUPLER DEVICE AND SYSTEM SYNOVIS LIFE TECHNOLOGIES, INC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact