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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Intranasal Septal, Cber Led
510(k) Number K160101
Device Name SinuBand
Applicant
BIOINSPIRE TECHNOLOGIES, INCORPORATED
2450 EMBARCADERO WAY
PALO ALTO,  CA  94303 -3313
Applicant Contact DORNA HAKIMIMEHR
Correspondent
BIOINSPIRE TECHNOLOGIES, INCORPORATED
2468 EMBARCADERO WAY
PALO ALTO,  CA  94303 -3313
Correspondent Contact Margaret Dillon
Regulation Number874.4780
Classification Product Code
QJL  
Date Received01/19/2016
Decision Date 07/27/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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