FDA 510(k) Application Details - K160170

Device Classification Name	System, Gastrointestinal Motility (Electrical)   More FDA Info for this Device
510(K) Number	K160170
Device Name	System, Gastrointestinal Motility (Electrical)
Applicant	Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-Salem, NC 27105 US Other 510(k) Applications for this Company
Contact	Doris A. Hawks 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	01/27/2016
Decision Date	06/20/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review