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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K150280
Device Name PulmoVia Working Channel
Applicant
SANOVAS, INC.
2597 Kerner Blvd
San Rafael,  CA  94901
Applicant Contact Roy Morgan
Correspondent
ICON plc
62 Forest Street
Suite 300
Marlborough,  MA  01752
Correspondent Contact Cynthia Nolte
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received02/05/2015
Decision Date 06/11/2015
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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