FDA 510(k) Application Details - K003445

Device Classification Name	Protector, Transducer, Dialysis   More FDA Info for this Device
510(K) Number	K003445
Device Name	Protector, Transducer, Dialysis
Applicant	FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. LEXINGTON, MA 02420-9192 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	11/06/2000
Decision Date	12/01/2000
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