FDA 510(k) Application Details - K130951

Device Classification Name	Alarm, Conditioned Response Enuresis   More FDA Info for this Device
510(K) Number	K130951
Device Name	Alarm, Conditioned Response Enuresis
Applicant	SIMAVITA PTY LIMITED 555 13TH ST. NW WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	JOHN J SMITH, MD,JD Other 510(k) Applications for this Contact
Regulation Number	876.2040   More FDA Info for this Regulation Number
Classification Product Code	KPN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/2013
Decision Date	08/22/2013
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