FDA 510(k) Application Details - K051814

Device Classification Name	Needle, Fistula   More FDA Info for this Device
510(K) Number	K051814
Device Name	Needle, Fistula
Applicant	JMS NORTH AMERICA CORP. 22320 FOOTHILL BLVD., SUITE 350 HAYWARD, CA 94541 US Other 510(k) Applications for this Company
Contact	CHONG SWEE CHEAU 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	07/05/2005
Decision Date	08/04/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review