FDA 510(k) Application Details - K193325

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K193325
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	ProSys International Ltd Suite 303, Highland House, 165 The Broadway Wimbledon SW19 1NE GB Other 510(k) Applications for this Company
Contact	Graham Steer Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2019
Decision Date	03/13/2020
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