FDA 510(k) Application Details - K042900

Device Classification Name	Set, Administration, For Peritoneal Dialysis, Disposable   More FDA Info for this Device
510(K) Number	K042900
Device Name	Set, Administration, For Peritoneal Dialysis, Disposable
Applicant	K.E.P., LLC 49 PLAIN STREET NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	ROSINA ROBINSON 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	10/19/2004
Decision Date	11/05/2004
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