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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 K152319
Device Name Auris Robotic Endoscopy System (ARES)
Applicant
AURIS SURGICAL ROBOTICS, INC.
125 SHOREWAY ROAD, SUITE D
SAN CARLOS,  CA  94070
Applicant Contact MICHAEL A. DANIEL
Correspondent
DANIEL & DANIEL CONSULTING, LLC
340 JONES LANE
GARDNERVILLE,  NV  89460
Correspondent Contact MICHAEL A. DANIEL
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received08/17/2015
Decision Date 05/26/2016
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
Predetermined Change
Control Plan Authorized		 No
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