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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K140595
Device Name THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM
Applicant
Avantis Medical Systems, Inc.
263 Santa Ana Ct.
Sunnyvale,  CA  94085
Applicant Contact LOUIS FRIES
Correspondent
Avantis Medical Systems, Inc.
263 Santa Ana Ct.
Sunnyvale,  CA  94085
Correspondent Contact LOUIS FRIES
Regulation Number876.1500
Classification Product Code
FDF  
Subsequent Product Code
FDS  
Date Received03/07/2014
Decision Date 11/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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