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FDA 510(k) Application Details - K190060
Device Classification Name
Catheter, Retention Type, Balloon
More FDA Info for this Device
510(K) Number
K190060
Device Name
Catheter, Retention Type, Balloon
Applicant
Urethrotech
24 Garth Road
Kingston upon Thames KT2 5NY GB
Other 510(k) Applications for this Company
Contact
Daniela Andrich
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
EZL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/11/2019
Decision Date
10/04/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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