FDA 510(k) Application Details - K023162

Device Classification Name	Needle, Fistula   More FDA Info for this Device
510(K) Number	K023162
Device Name	Needle, Fistula
Applicant	FRESENIUS MEDICAL CARE 95 HAYDEN AVE. LEXINGTON, MA 02420 US Other 510(k) Applications for this Company
Contact	NICHOLE RIEK Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	FIE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/23/2002
Decision Date	03/20/2003
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