FDA 510(k) Application Details - K162176

Device Classification Name	More FDA Info for this Device
510(K) Number	K162176
Device Name	Fiagon Navigation System
Applicant	Fiagon GmbH Neuendorfstrasse 23b Hennigsdorf 16761 DE Other 510(k) Applications for this Company
Contact	Dirk Mucha Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/03/2016
Decision Date	12/01/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review