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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ent Manual Surgical
510(k) Number K160770
Device Name Vent-Os Sinus Dilation family
Applicant
SINUSYS CORPORATION
2468 EMBARCADERO WAY
Palo Alto,  CA  94303
Applicant Contact Lloyd H. Griese
Correspondent
SINUSYS CORPORATION
2468 EMBARCADERO WAY
Palo Alto,  CA  94303
Correspondent Contact Lloyd H. Griese
Regulation Number874.4420
Classification Product Code
LRC  
Date Received03/21/2016
Decision Date 06/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT02463279
Reviewed by Third Party No
Combination Product No
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