FDA 510(k) Application Details - K981591

Device Classification Name	Stent, Ureteral   More FDA Info for this Device
510(K) Number	K981591
Device Name	Stent, Ureteral
Applicant	INTERNATIONAL REGULATORY CONSULTANTS 2471 E. SHADOW WOOD CIRCLE P.O. BOX 17801 SALT LAKE CITY, UT 84117 US Other 510(k) Applications for this Company
Contact	DONALD F GRABARZ Other 510(k) Applications for this Contact
Regulation Number	876.4620   More FDA Info for this Regulation Number
Classification Product Code	FAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/1998
Decision Date	10/09/1998
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