FDA 510(k) Application Details - K131659

Device Classification Name	Catheter, Irrigation   More FDA Info for this Device
510(K) Number	K131659
Device Name	Catheter, Irrigation
Applicant	MOERAE MATRIX, INC. 25 HARTFORD AVENUE SAN CARLOS, CA 94070 US Other 510(k) Applications for this Company
Contact	ROBERT J CHIN Other 510(k) Applications for this Contact
Regulation Number	878.4200   More FDA Info for this Regulation Number
Classification Product Code	GBX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2013
Decision Date	03/03/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review