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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
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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
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