FDA 510(k) Application Details - K181020

Device Classification Name	Esophagoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K181020
Device Name	Esophagoscope (Flexible Or Rigid)
Applicant	Covidien llc 15 Hampshire Street Mansfield, MA 02048 US Other 510(k) Applications for this Company
Contact	Rachel Silva Other 510(k) Applications for this Contact
Regulation Number	874.4710   More FDA Info for this Regulation Number
Classification Product Code	EOX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2018
Decision Date	08/16/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review