FDA 510(k) Application Details - K012988

Device Classification Name	System, Peritoneal, Automatic Delivery   More FDA Info for this Device
510(K) Number	K012988
Device Name	System, Peritoneal, Automatic Delivery
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	FKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/06/2001
Decision Date	12/05/2001
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