FDA 510(k) Application Details - K083687

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K083687
Device Name	Set, Administration, Intravascular
Applicant	ANHUI KANGDA MEDICAL PRODUCTS CO., LTD. 1707 YINQIAO BLDG. 58 JINXIN RD., JINQIAO PUDONG, SHANGHAI 201206 CN Other 510(k) Applications for this Company
Contact	BIAN WEI QIANG 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	12/12/2008
Decision Date	06/11/2009
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