FDA 510(k) Application Details - K152794

Device Classification Name	Esophagoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K152794
Device Name	Esophagoscope (Flexible Or Rigid)
Applicant	Covidien LLC 15 Hampshire Street Mansfield, MA 020408 US Other 510(k) Applications for this Company
Contact	Clare Santulli 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	09/28/2015
Decision Date	04/12/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review