FDA 510(k) Application Details - K191067

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K191067
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	Boddingtons Plastics Ltd Wheelbarrow Park Estate, Pattenden Lane, Marden Tonbridge Tn12 9QJ GB Other 510(k) Applications for this Company
Contact	Shimaa Elsawy Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2019
Decision Date	05/30/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review