FDA 510(k) Application Details - K954713

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K954713
Device Name	Catheter, Biliary, Diagnostic
Applicant	IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 CLEARWATER, FL 34622 US Other 510(k) Applications for this Company
Contact	ELIZABETH M PAUL 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	10/10/1995
Decision Date	07/24/1996
Decision	SESE - SUBST EQUIV
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