FDA 510(k) Application Details - K043363

Device Classification Name	System, Peritoneal, Automatic Delivery   More FDA Info for this Device
510(K) Number	K043363
Device Name	System, Peritoneal, Automatic Delivery
Applicant	FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. LEXINGTON, MA 02420-9192 US Other 510(k) Applications for this Company
Contact	ARTHUR EILINSFELD 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	12/07/2004
Decision Date	03/31/2005
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