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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 K083180
Device Name THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
Applicant
AVANTIS MEDICAL SYSTEMS, INC.
263 SANTA ANA CT.
SUNNYVALE,  CA  94085
Applicant Contact AMRITA SETHI
Correspondent
AVANTIS MEDICAL SYSTEMS, INC.
263 SANTA ANA CT.
SUNNYVALE,  CA  94085
Correspondent Contact AMRITA SETHI
Regulation Number876.1500
Classification Product Code
FDF  
Subsequent Product Code
ODA  
Date Received10/28/2008
Decision Date 02/12/2009
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
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