FDA 510(k) Application Details - K183085

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K183085
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Elena Nieves 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	11/06/2018
Decision Date	03/08/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review