FDA 510(k) Application Details - K103349

Device Classification Name	Catheter, Urological   More FDA Info for this Device
510(K) Number	K103349
Device Name	Catheter, Urological
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	876.5130   More FDA Info for this Regulation Number
Classification Product Code	KOD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2010
Decision Date	01/07/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review