FDA 510(k) Application Details - K000702

Device Classification Name	Protector, Transducer, Dialysis   More FDA Info for this Device
510(K) Number	K000702
Device Name	Protector, Transducer, Dialysis
Applicant	FRESENIUS MEDICAL CARE NORTH AMERICA TWO LEDGEMONT CENTER 95 HAYDEN AVENUE LEXINGTON, MA 02420 US Other 510(k) Applications for this Company
Contact	ARTHUR EILINSFELD Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FIB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2000
Decision Date	06/07/2000
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