FDA 510(k) Application Details - K970962

Device Classification Name	Needle, Fistula   More FDA Info for this Device
510(K) Number	K970962
Device Name	Needle, Fistula
Applicant	JMS CO., LTD. 12,17,KAKO-MACHI,NAKA-KU HIROSHIMA, 730 JP Other 510(k) Applications for this Company
Contact	T HIROSE 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	03/17/1997
Decision Date	08/07/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review