FDA 510(k) Application Details - K061515

Device Classification Name	System, Dialysate Delivery, Semi-Automatic, Peritoneal   More FDA Info for this Device
510(K) Number	K061515
Device Name	System, Dialysate Delivery, Semi-Automatic, Peritoneal
Applicant	BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD MCGAW PARK, IL 60085 US Other 510(k) Applications for this Company
Contact	DAVID E CURTIN Other 510(k) Applications for this Contact
Regulation Number	876.5630   More FDA Info for this Regulation Number
Classification Product Code	KPF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2006
Decision Date	09/11/2006
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