FDA 510(k) Application Details - K083049

Device Classification Name	Snare, Flexible   More FDA Info for this Device
510(K) Number	K083049
Device Name	Snare, Flexible
Applicant	HORIZONS INTL. CORP. P.O. BOX 213-3006 ZONA FRANCA METRO BARREAL DE HEREDIA CR Other 510(k) Applications for this Company
Contact	RAFIC SALEH Other 510(k) Applications for this Contact
Regulation Number	876.4300   More FDA Info for this Regulation Number
Classification Product Code	FDI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/2008
Decision Date	12/23/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review