FDA 510(k) Application Details - K083542

Device Classification Name	Set, Administration, For Peritoneal Dialysis, Disposable   More FDA Info for this Device
510(K) Number	K083542
Device Name	Set, Administration, For Peritoneal Dialysis, Disposable
Applicant	FRESENIUS MEDICAL CARE NORTH AMERICA 920 Winter Street Waltham, MA 02451-1457 US Other 510(k) Applications for this Company
Contact	JANET KAY 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	11/28/2008
Decision Date	12/29/2008
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