FDA 510(k) Application Details - K250404

Device Classification Name	Set, Administration, For Peritoneal Dialysis, Disposable   More FDA Info for this Device
510(K) Number	K250404
Device Name	Set, Administration, For Peritoneal Dialysis, Disposable
Applicant	Fresenius Medical Care Renal Therapies Group, LLC 920 Winter St Waltham, MA 02451 US Other 510(k) Applications for this Company
Contact	Caitlin Kalda Other 510(k) Applications for this Contact
Regulation Number	876.5630   More FDA Info for this Regulation Number
Classification Product Code	KDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2025
Decision Date	04/03/2025
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