FDA 510(k) Application Details - K181108

Device Classification Name	System, Peritoneal, Automatic Delivery   More FDA Info for this Device
510(K) Number	K181108
Device Name	System, Peritoneal, Automatic Delivery
Applicant	Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451 US Other 510(k) Applications for this Company
Contact	Denise Oppermann Other 510(k) Applications for this Contact
Regulation Number	876.5630   More FDA Info for this Regulation Number
Classification Product Code	FKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2018
Decision Date	05/24/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review