FDA 510(k) Application Details - K990953

Device Classification Name	System, Dialysate Delivery, Semi-Automatic, Peritoneal   More FDA Info for this Device
510(K) Number	K990953
Device Name	System, Dialysate Delivery, Semi-Automatic, Peritoneal
Applicant	BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD 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	03/22/1999
Decision Date	06/18/1999
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