FDA 510(k) Application Details - K003712

Device Classification Name	Accessories, Blood Circuit, Hemodialysis   More FDA Info for this Device
510(K) Number	K003712
Device Name	Accessories, Blood Circuit, Hemodialysis
Applicant	MOLDED PRODUCTS INC. P.O. BOX 15 HARLAN, IA 51537 US Other 510(k) Applications for this Company
Contact	ELISE JOHNSTON Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	KOC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/01/2000
Decision Date	05/16/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review