FDA 510(k) Application Details - K160171

Device Classification Name	Mediastinoscope, Surgical   More FDA Info for this Device
510(K) Number	K160171
Device Name	Mediastinoscope, Surgical
Applicant	Aegis Surgical Ltd 4020 Stirrup Creek Drive Suite 115 Durham, NC 27703 US Other 510(k) Applications for this Company
Contact	William Starling Other 510(k) Applications for this Contact
Regulation Number	874.4720   More FDA Info for this Regulation Number
Classification Product Code	EWY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/27/2016
Decision Date	02/26/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review