FDA 510(k) Application Details - K151976

Device Classification Name	Electrode, Electrosurgical, Active, Urological   More FDA Info for this Device
510(K) Number	K151976
Device Name	Electrode, Electrosurgical, Active, Urological
Applicant	OMNITECH SYSTEMS, INC. 450 SOUTH CAMPBELL ST. SUITE #2 VALPARAISO, IN 46385 US Other 510(k) Applications for this Company
Contact	JON D. BARRETT Other 510(k) Applications for this Contact
Regulation Number	876.4300   More FDA Info for this Regulation Number
Classification Product Code	FAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/16/2015
Decision Date	06/27/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review