FDA 510(k) Application Details - K024007

Device Classification Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days   More FDA Info for this Device
510(K) Number	K024007
Device Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant	SUNDER BIOMEDICAL TECH. CO., LTD. 10F-1, 1-67, WU-CHUAN RD. TAICHUNG CITY 403 TW Other 510(k) Applications for this Company
Contact	TONY HUNG 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	12/04/2002
Decision Date	07/14/2003
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