FDA 510(k) Application Details - K113148

Device Classification Name	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K113148
Device Name	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant	SYNEXMED(SHENZHEN)COMPANY LIMITED B-11/F,Z Z Y BUILD.,TAOHUA RD. FUTIAN FREE TRADE ZONE SHENZHEN 518038 CN Other 510(k) Applications for this Company
Contact	TONY ZHANG Other 510(k) Applications for this Contact
Regulation Number	870.4290   More FDA Info for this Regulation Number
Classification Product Code	DTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/24/2011
Decision Date	02/28/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review