FDA 510(k) Application Details - K010549

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K010549
Device Name	Catheter, Biliary, Diagnostic
Applicant	MEDI-GLOBE CORP. 6202 SOUTH MAPLE AVE. # 131 TEMPE, AZ 85283 US Other 510(k) Applications for this Company
Contact	SCOTT KARLER 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	02/26/2001
Decision Date	01/18/2002
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review