FDA 510(k) Application Details - K061009

Device Classification Name	Dilator, Catheter, Ureteral   More FDA Info for this Device
510(K) Number	K061009
Device Name	Dilator, Catheter, Ureteral
Applicant	ONSET MEDICAL CORPORATION 27001 LA PAZ SUITE 312 MISSION VIEJO, CA 92691 US Other 510(k) Applications for this Company
Contact	ALBERT REGO Other 510(k) Applications for this Contact
Regulation Number	876.5470   More FDA Info for this Regulation Number
Classification Product Code	EZN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/12/2006
Decision Date	05/02/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review