FDA 510(k) Application Details - K090430

Device Classification Name	Dissolvable Gel For Preventing Ureteral Stone Migration   More FDA Info for this Device
510(K) Number	K090430
Device Name	Dissolvable Gel For Preventing Ureteral Stone Migration
Applicant	PLUROMED, INC. 25-H OLYMPIA AVENUE WOBURN, MA 01801 US Other 510(k) Applications for this Company
Contact	JAMES WILKIE Other 510(k) Applications for this Contact
Regulation Number	876.4680   More FDA Info for this Regulation Number
Classification Product Code	ONJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2009
Decision Date	06/02/2009
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