FDA 510(k) Application Details - K160101

Device Classification Name	More FDA Info for this Device
510(K) Number	K160101
Device Name	SinuBand
Applicant	BIOINSPIRE TECHNOLOGIES, INCORPORATED 2450 EMBARCADERO WAY PALO ALTO, CA 94303-3313 US Other 510(k) Applications for this Company
Contact	DORNA HAKIMIMEHR Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/19/2016
Decision Date	07/27/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review