FDA 510(k) Application Details - K093043

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K093043
Device Name	Needle, Hypodermic, Single Lumen
Applicant	KUO TAI HOSPITAL MANAGEMENTS & CONSULTANT CO., LTD 2F-1, NO.27, TAYOU RD., SONGSHAN DISTRICT TAIPEI 10585 TW Other 510(k) Applications for this Company
Contact	CHAO-SHENT CHAO 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	09/30/2009
Decision Date	08/20/2010
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