FDA 510(k) Application Details - K002235

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K002235
Device Name	Catheter, Biliary, Diagnostic
Applicant	HORIZONS INTL. CORP. 200 POLITECNICA ST. VILLAS UNIV. PO BOX 250435 AGUADILLA, PR 00604 US Other 510(k) Applications for this Company
Contact	RAFIC SALEH Other 510(k) Applications for this Contact
Regulation Number	876.5010   More FDA Info for this Regulation Number
Classification Product Code	FGE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/24/2000
Decision Date	01/23/2001
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