FDA 510(k) Application Details - K033210

Device Classification Name	Stent, Ureteral   More FDA Info for this Device
510(K) Number	K033210
Device Name	Stent, Ureteral
Applicant	BIOTEQUE CORP. 3892 SOUTH AMERICA WEST TRAIL FLAGGSTAFF, AZ 86001 US Other 510(k) Applications for this Company
Contact	JENNIFER REICH 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	10/03/2003
Decision Date	12/30/2004
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