FDA 510(k) Application Details - K071382

Device Classification Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days   More FDA Info for this Device
510(K) Number	K071382
Device Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant	SHIN CHANG MEDICAL CO., LTD. 3762 SOUTH 150 EAST SALT LAKE CITY, UT 84115 US Other 510(k) Applications for this Company
Contact	JAN J FRANK Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	FOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/2007
Decision Date	10/16/2007
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