FDA 510(k) Application Details - K070451

Device Classification Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days   More FDA Info for this Device
510(K) Number	K070451
Device Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant	FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD SUITE 8D, NO.19 LANE 999, ZHONG SHAN NAN ER ROAD SHANGHAI 528200 CN Other 510(k) Applications for this Company
Contact	Diana Hong 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	02/15/2007
Decision Date	07/31/2007
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