FDA 510(k) Application Details - K002813

Device Classification Name	Needle, Fistula   More FDA Info for this Device
510(K) Number	K002813
Device Name	Needle, Fistula
Applicant	NIPRO MEDICAL CORP. 510 STONEMONT DR. WESTON, FL 33326 US Other 510(k) Applications for this Company
Contact	RICHARD D BLISS 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	09/08/2000
Decision Date	11/21/2000
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