FDA 510(k) Application Details - K032888

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K032888
Device Name	Catheter, Intravascular, Diagnostic
Applicant	NEICH MEDICAL (SHENZHEN) COMPANY LIMITED 1 JINKUI ROAD, FUTIAN FREE TRADE ZONE SHENZHEN, GUANGDONG P.R.O.C. 518038 CN Other 510(k) Applications for this Company
Contact	RAYMOND LIN Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/2003
Decision Date	02/24/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review