FDA 510(k) Application Details - K131852

Device Classification Name	Colonic Irrigation System   More FDA Info for this Device
510(K) Number	K131852
Device Name	Colonic Irrigation System
Applicant	TRANSCENDENCIAS COMERCIALES SL TRANSCOM C/ZUBIBERRI 31- PLANTA BAJA LOCAL 1 SAN SEBASTIAN, GUIPUZCOA 20018 ES Other 510(k) Applications for this Company
Contact	RAMON ECHEVARRIA Other 510(k) Applications for this Contact
Regulation Number	876.5220   More FDA Info for this Regulation Number
Classification Product Code	KPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2013
Decision Date	04/17/2014
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