FDA 510(k) Application Details - K120191

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K120191
Device Name	Needle, Hypodermic, Single Lumen
Applicant	SCANDINAVIAN HEALTH LIMITED NO. 136, KUO SHENG 2ND STREET TAOYUAN CITY 33060 TW Other 510(k) Applications for this Company
Contact	SHARLIN YEH 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	01/23/2012
Decision Date	05/23/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review