FDA 510(k) Application Details - K955413

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K955413
Device Name	Catheter, Biliary, Diagnostic
Applicant	ENDOVATIONS HILL AND GEORGE AVENUES P.O. BOX 6386 READING, PA 19610 US Other 510(k) Applications for this Company
Contact	RONALD D WOLFE 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	11/27/1995
Decision Date	02/08/1996
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