FDA 510(k) Application Details - K071909

Device Classification Name	Accessories, Blood Circuit, Hemodialysis   More FDA Info for this Device
510(K) Number	K071909
Device Name	Accessories, Blood Circuit, Hemodialysis
Applicant	BARKEY GMBH & CO. KG GEWERBESTRASSE 8 LEOPOLDSHOEHE D-33818 DE Other 510(k) Applications for this Company
Contact	THOMAS BARKEY 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	07/11/2007
Decision Date	10/18/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review