MODIFICATION TO THIRD EYE RETROSCOPE 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 Modification To Third Eye Retroscope Auxiliary Endoscopy System.

Pre-market Notification Details

Device IDK093187
510k NumberK093187
Device Name:MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
ClassificationColonoscope And Accessories, Flexible/rigid
Applicant AVANTIS MEDICAL SYSTEMS, INC. 263 SANTA ANA CT. Sunnyvale,  CA  94085
ContactElaine Aplaon
CorrespondentElaine Aplaon
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 Received2009-10-09
Decision Date2009-11-05
Summary:summary

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