FDA 510(k) Application Details - K163537

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K163537
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Covidien llc 161 Cheshire Lane, Suite 100 Plymouth, MN 55441 US Other 510(k) Applications for this Company
Contact	LeeAnne Swiridow Other 510(k) Applications for this Contact
Regulation Number	874.4680   More FDA Info for this Regulation Number
Classification Product Code	EOQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2016
Decision Date	04/21/2017
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