FDA 510(k) Application Details - K190163

Device Classification Name	More FDA Info for this Device
510(K) Number	K190163
Device Name	ALARA Neuro Access Kit
Applicant	SurGenTec, LLC 7601 N Federal Highway #150A Boca Raton, FL 33487 US Other 510(k) Applications for this Company
Contact	Travis Greenhalgh Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2019
Decision Date	07/16/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review