FDA 510(k) Application Details - K200483

Device Classification Name	Choledochoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K200483
Device Name	Choledochoscope And Accessories, Flexible/Rigid
Applicant	Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Inderdeep Tiwana Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FBN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2020
Decision Date	05/21/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review