THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM

Colonoscope And Accessories, Flexible/rigid

AVANTIS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Avantis Medical Systems, Inc. with the FDA for Third Eye Retroscope Auxiliary Endoscope System.

Pre-market Notification Details

Device IDK091783
510k NumberK091783
Device Name:THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM
ClassificationColonoscope And Accessories, Flexible/rigid
Applicant AVANTIS MEDICAL SYSTEMS, INC. 263 SANTA ANA CT. Sunnyvale,  CA  94085
ContactAmrita Sethi
CorrespondentAmrita Sethi
AVANTIS MEDICAL SYSTEMS, INC. 263 SANTA ANA CT. Sunnyvale,  CA  94085
Product CodeFDF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-17
Decision Date2009-07-07
Summary:summary

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