FDA 510(k) Application Details - K153688

Device Classification Name	More FDA Info for this Device
510(K) Number	K153688
Device Name	Edi Catheter ENFit
Applicant	MAQUET CRITICAL CARE AB RONTGENVAGEN 2 SOLNA SE-171 54 SE Other 510(k) Applications for this Company
Contact	MIRVA BOOTHE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2015
Decision Date	03/02/2017
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