THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY 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 Panoramic Auxiliary Endoscopy System.

Pre-market Notification Details

Device IDK140595
510k NumberK140595
Device Name:THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM
ClassificationColonoscope And Accessories, Flexible/rigid
Applicant AVANTIS MEDICAL SYSTEMS, INC. 263 SANTA ANA CT. Sunnyvale,  CA  94085
ContactLouis Fries
CorrespondentLouis Fries
AVANTIS MEDICAL SYSTEMS, INC. 263 SANTA ANA CT. Sunnyvale,  CA  94085
Product CodeFDF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-07
Decision Date2014-11-17
Summary:summary

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