FDA 510(k) Application Details - K131144

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K131144
Device Name	Introducer, Catheter
Applicant	AMECO MEDICAL INDUSTRIES 57 LAZY BROOK RD MONROE, CT 06468 US Other 510(k) Applications for this Company
Contact	RAYMOND J KELLY Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2013
Decision Date	08/15/2013
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