FDA 510(k) Application Details - K010366

Device Classification Name	Dialyzer, Capillary, Hollow Fiber   More FDA Info for this Device
510(K) Number	K010366
Device Name	Dialyzer, Capillary, Hollow Fiber
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	FJI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/07/2001
Decision Date	11/28/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review