FDA 510(k) Application Details - K992391

Device Classification Name	Stent, Ureteral   More FDA Info for this Device
510(K) Number	K992391
Device Name	Stent, Ureteral
Applicant	UROSURGE, INC. 2660 CROSSPARK RD. CORALVILLE, IA 52241 US Other 510(k) Applications for this Company
Contact	STEVEN J PREISS 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	07/19/1999
Decision Date	08/18/1999
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