FDA 510(k) Application Details - K191563

Device Classification Name	System, Water Purification, General Medical Use   More FDA Info for this Device
510(K) Number	K191563
Device Name	System, Water Purification, General Medical Use
Applicant	aqua-tools 26, rue Charles Edouard Jeanneret Poissy 78300 FR Other 510(k) Applications for this Company
Contact	Virginie S. Grondin Other 510(k) Applications for this Contact
Regulation Number	876.5665   More FDA Info for this Regulation Number
Classification Product Code	NHV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/13/2019
Decision Date	10/25/2019
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