FDA 510(k) Application Details - K200723

Device Classification Name	More FDA Info for this Device
510(K) Number	K200723
Device Name	StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
Applicant	Medtronic Navigation Inc. 826 Coal Creek Circle Louisville, CO 80027 US Other 510(k) Applications for this Company
Contact	Carey Brenner 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	03/19/2020
Decision Date	06/26/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review