FDA 510(k) Application Details - K955182

Device Classification Name	Needle, Fistula   More FDA Info for this Device
510(K) Number	K955182
Device Name	Needle, Fistula
Applicant	NISSHO CORP. 7205 CORPORATE CENTER DR. # 305 MIAMI, FL 33126 US Other 510(k) Applications for this Company
Contact	LUIS CANDELARIO 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	11/13/1995
Decision Date	06/04/1996
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