FDA 510(k) Application Details - K192357

Device Classification Name	More FDA Info for this Device
510(K) Number	K192357
Device Name	INNOVO
Applicant	Atlantic Therapeutics Ltd. Parkmore Business Park West Galway H91 NHT7 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	08/29/2019
Decision Date	01/16/2020
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