FDA 510(k) Application Details - K043418

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K043418
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 SPENCER, IN 47460 US Other 510(k) Applications for this Company
Contact	CINDY RUMPLE Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2004
Decision Date	03/31/2005
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