FDA 510(k) Application Details - K163469

Device Classification Name	Bronchoscope Accessory   More FDA Info for this Device
510(K) Number	K163469
Device Name	Bronchoscope Accessory
Applicant	Olympus Surgical Technologies America 136 Turnpike Road Southborough, MA 01772-2104 US Other 510(k) Applications for this Company
Contact	Mary Anne Patella Other 510(k) Applications for this Contact
Regulation Number	874.4680   More FDA Info for this Regulation Number
Classification Product Code	KTI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2016
Decision Date	04/06/2017
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