FDA 510(k) Application Details - DEN170049

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170049
Device Name	Innovo
Applicant	Bio-Medical Research Ltd. Parkmore Business Park West Galway H91NHT7 IE Other 510(k) Applications for this Company
Contact	Anne-Marie Keenan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/2017
Decision Date	11/06/2018
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review