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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 K091783
Device Name THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE 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  
Date Received06/17/2009
Decision Date 07/07/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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