FDA 510(k) Application Details - K011148

Device Classification Name	Dialyzer, Capillary, Hollow Fiber   More FDA Info for this Device
510(K) Number	K011148
Device Name	Dialyzer, Capillary, Hollow Fiber
Applicant	INTERPORE CROSS INTL. 181 TECHNOLOGY DR. IRVINE, CA 92618-2402 US Other 510(k) Applications for this Company
Contact	PROSIE REY-FESSLER 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	04/16/2001
Decision Date	06/13/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review