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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 K133016
Device Name VENT-OS SINUS DILATION SYSTEM
Applicant
Sinusys Corporation
8 Snowberry Ct.
Orinda,  CA  94563
Applicant Contact MICHAELE A DANIEL
Correspondent
Sinusys Corporation
8 Snowberry Ct.
Orinda,  CA  94563
Correspondent Contact MICHAELE A DANIEL
Regulation Number874.4420
Classification Product Code
LRC  
Date Received09/25/2013
Decision Date 12/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT01623050
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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