FDA 510(k) Application Details - K111405

Device Classification Name	Catheter, Urethral   More FDA Info for this Device
510(K) Number	K111405
Device Name	Catheter, Urethral
Applicant	HANGZHOU BEVER MEDICAL DEVICES CO., LTD. NO. 8-1, LONGQUAN ROAD CANGQIAN TOWN, YUHANG DISTRICT HANGZHOU, ZHEJIANG 311121 CN Other 510(k) Applications for this Company
Contact	ALLYSON ZHOU Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	GBM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/19/2011
Decision Date	02/13/2012
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