FDA 510(k) Application Details - K002394

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K002394
Device Name	Needle, Hypodermic, Single Lumen
Applicant	JMS CO., LTD. 12-17, KAKO-MACHI, NAKA-KU HIROSHIMA 730-8652 JP Other 510(k) Applications for this Company
Contact	KEISUKE URATOMI Other 510(k) Applications for this Contact
Regulation Number	880.5570   More FDA Info for this Regulation Number
Classification Product Code	FMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2000
Decision Date	09/05/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review