FDA 510(k) Application Details - K132943

Device Classification Name	Trocar   More FDA Info for this Device
510(K) Number	K132943
Device Name	Trocar
Applicant	SYNAPTIC MEDICAL LIMITED P.O. BOX 120-119 SHANGHAI 200120 CN Other 510(k) Applications for this Company
Contact	Diana Hong Other 510(k) Applications for this Contact
Regulation Number	870.1390   More FDA Info for this Regulation Number
Classification Product Code	DRC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/2013
Decision Date	08/29/2014
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