Third Eye Panoramic Auxiliary Endoscopy System - Resposable

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 - Resposable.

Pre-market Notification Details

Device IDK160356
510k NumberK160356
Device Name:Third Eye Panoramic Auxiliary Endoscopy System - Resposable
ClassificationColonoscope And Accessories, Flexible/rigid
Applicant AVANTIS MEDICAL SYSTEMS, INC. 2367 BERING DRIVE San Jose,  CA  95131
ContactLouis Fries
CorrespondentLouis Fries
AVANTIS MEDICAL SYSTEMS, INC. 2367 BERING DRIVE San Jose,  CA  95131
Product CodeFDF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-08
Decision Date2016-05-17
Summary:summary

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