FDA 510(k) Application Details - K050992

Device Classification Name	Colonic Irrigation System   More FDA Info for this Device
510(K) Number	K050992
Device Name	Colonic Irrigation System
Applicant	CONMED CORP. 525 FRENCH RD. UTICA, NY 13502 US Other 510(k) Applications for this Company
Contact	IRA DUESLER Other 510(k) Applications for this Contact
Regulation Number	876.5220   More FDA Info for this Regulation Number
Classification Product Code	KPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2005
Decision Date	07/14/2005
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