FDA 510(k) Application Details - K112204

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K112204
Device Name	Set, Administration, Intravascular
Applicant	SHANGHAI KINDLY ENT. DEVELOPMENT GROUP CO., LTD. P.O. BOX 237-023 SHANGHAI 200237 CN Other 510(k) Applications for this Company
Contact	Diana Hong Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2011
Decision Date	09/10/2012
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