FDA 510(k) Application Details - K031676

Device Classification Name	Set, Administration, For Peritoneal Dialysis, Disposable   More FDA Info for this Device
510(K) Number	K031676
Device Name	Set, Administration, For Peritoneal Dialysis, Disposable
Applicant	BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD., MPR-A2E MCGAW PARK, IL 60085-6730 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	KDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2003
Decision Date	11/20/2003
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