FDA 510(k) Application Details - K160725

Device Classification Name	System, Gastrointestinal Motility (Electrical)   More FDA Info for this Device
510(K) Number	K160725
Device Name	System, Gastrointestinal Motility (Electrical)
Applicant	CROSPON LTD. GALWAY BUSINESS PARK, DANGAN GALWAY IE Other 510(k) Applications for this Company
Contact	JOHN O'DEA Other 510(k) Applications for this Contact
Regulation Number	876.1725   More FDA Info for this Regulation Number
Classification Product Code	FFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2016
Decision Date	05/01/2016
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