FDA 510(k) Application Details - K182895

Device Classification Name	More FDA Info for this Device
510(K) Number	K182895
Device Name	Wilson-Cook Achalasia Balloon
Applicant	Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-Salem, NC 27105 US Other 510(k) Applications for this Company
Contact	Theresa de Prat Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PID Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2018
Decision Date	01/25/2019
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