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 Third Eye Retroscope Auxiliary Endoscopy System.

Pre-market Notification Details

Device IDK070330
510k NumberK070330
Device Name:THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
ClassificationColonoscope And Accessories, Flexible/rigid
Applicant AVANTIS MEDICAL SYSTEMS, INC. 263 SANTA ANA CT. Sunnyvale,  CA  94085
ContactScott Rutherford
CorrespondentScott Rutherford
AVANTIS MEDICAL SYSTEMS, INC. 263 SANTA ANA CT. Sunnyvale,  CA  94085
Product CodeFDF  
Subsequent Product CodeFCQ
Subsequent Product CodeFDS
Subsequent Product CodeKNW
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-02-05
Decision Date2007-04-24
Summary:summary

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