FDA 510(k) Application Details - K991623

Device Classification Name	Needle, Fistula   More FDA Info for this Device
510(K) Number	K991623
Device Name	Needle, Fistula
Applicant	NIPRO MEDICAL CORP. 1384 COPPERFIELD COURT LEXINGTON, KY 40514-1268 US Other 510(k) Applications for this Company
Contact	KAELYN HADLEY 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	05/11/1999
Decision Date	08/09/1999
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