FDA 510(k) Application Details - K201159

Device Classification Name	Stent, Colonic, Metalic, Expandable   More FDA Info for this Device
510(K) Number	K201159
Device Name	Stent, Colonic, Metalic, Expandable
Applicant	Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Catherine Sanford Other 510(k) Applications for this Contact
Regulation Number	878.3610   More FDA Info for this Regulation Number
Classification Product Code	MQR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2020
Decision Date	08/17/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review